Accessories, Implant, Dental, Endosseous
Regulation 872.3980
0510(k)s in 12 months (4 all time)
1recalls in 12 months (57 all time)
2recalls that name a 510(k)
Top companies in NDP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2026 | Straumann USA LLC WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM Open, Classified |
NDP | None listed |
| Aug 25, 2025 | Dentsply IH, Inc. Brand Name: Atlantis IO FLO
Product Name: Atlantis IO FLO-S Kit
Model/Catalog Number: A04S / 6802034
Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) Open, Classified |
NDP | None listed |
| Aug 25, 2025 | Dentsply IH, Inc. Brand Name: Atlantis IO FLO-S
Product Name: Atlantis IO FLO-S Kit
Model/Catalog Number: A04B / 68020033
Software Version: n/a
Product Description: The Atlantis intraoral feature locating object for su Open, Classified |
NDP | None listed |
| May 28, 2025 | Prismatik Dentalcraft, Inc. Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266
UDI code: +D7457071SRG02660/$$76254798/16D20250219V
The Glidewell HT" Implant Twist Drill is indicated to prepare the site for plac Open, Classified |
NDP | None listed |
| Apr 14, 2025 | Straumann USA LLC TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; Open, Classified |
NDP | None listed |
| Mar 11, 2025 | TruAbutment Inc. Brand Name: TruScan Body, REF CN38-SB
Product Name: TruScan Body compatible with CONELOG 3.8
Model/Catalog Number: CN38-SB
Software Version: N/A Open, Classified |
NDP | None listed |
| Aug 19, 2024 | Preat Corp Multiple Digital Analog Products labeled as:
NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703
Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303
3i Certain-compatible 5 Open, Classified |
NDP | None listed |
| Mar 20, 2024 | Thommen Medical AG impression coping, repositionable, short, screw-retained, PF 4.0 Open, Classified |
NDP | None listed |
| Jul 26, 2021 | Paltop Advanced Dental Solutions Ltd Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Terminated |
NDP | None listed |
| Jul 26, 2021 | Paltop Advanced Dental Solutions Ltd Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. Th Terminated |
NDP | None listed |
| Jul 26, 2021 | Paltop Advanced Dental Solutions Ltd Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Terminated |
NDP | None listed |
| Jul 26, 2021 | Paltop Advanced Dental Solutions Ltd Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Terminated |
NDP | None listed |
| Jul 26, 2021 | Paltop Advanced Dental Solutions Ltd Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Terminated |
NDP | None listed |
| Jul 26, 2021 | Paltop Advanced Dental Solutions Ltd Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Terminated |
NDP | None listed |
| May 27, 2021 | Straumann USA LLC Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel
Article Number: 046.401. dental surgical instrument. Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implan Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant s Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal con Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with inter Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical conne Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal c Terminated |
NDP | None listed |
| Apr 3, 2019 | Thommen Medical AG Adapter for handpiece, guided, reusable, for guide sleeve
0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer t Terminated |
NDP | None listed |
| Nov 28, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. Completed |
NDP | None listed |
| Nov 28, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. Completed |
NDP | None listed |
| Sep 6, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ Terminated |
NDP | None listed |
| May 29, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure. Terminated |
NDP | None listed |
| Jan 24, 2018 | Keystone Dental Inc Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K.
Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. Terminated |
NDP | None listed |
| Nov 15, 2017 | Implant Direct Sybron Manufacturing, LLC Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK)
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create Terminated |
NDP | None listed |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous Terminated |
NDP | None listed |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous Terminated |
NDP | None listed |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous dental implant access Terminated |
NDP | None listed |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous dental implant accessories are manually powered devices intended Terminated |
NDP | None listed |
| Jul 10, 2017 | Zimmer Dental Inc WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A;
WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S;
WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A;
WAXING COPING, CONT 4.5MM, REF ZOCWAX4S;
WAXING COPING, CONT, Terminated |
NDP | None listed |
| Jul 10, 2017 | Zimmer Dental Inc IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A;
MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S;
IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A;
IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S;
IMPRESSION CAP,CONT,5 Terminated |
NDP | None listed |
| Jul 10, 2017 | Zimmer Dental Inc TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34;
TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45;
TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56;
TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT Terminated |
NDP | None listed |
| Jul 10, 2017 | Zimmer Dental Inc Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223 Terminated |
NDP | None listed |
| Apr 7, 2017 | Instradent USA, Inc. NEODENT CM Intraoral Scanbody, Article Number: 108.139 Terminated |
NDP | None listed |
| Nov 23, 2016 | Straumann Manufacturing, Inc. Straumann Twist Drill PRO 4.2mm,long,41mm,SS-Non sterile. Dental implant accessory
Article Number: 044.255
Dental implants drill accessory is intended to prepare osteotomy site for surgical dental Terminated |
NDP | None listed |
| Nov 23, 2016 | Straumann Manufacturing, Inc. Straumann Drill 1, short, 2.2mm, l 33.0mm, SS-Non sterile.
Dental implant accessory
Article Number: 044.210
Dental implants drill accessory is intended to prepare osteotomy site for surgical dental Terminated |
NDP | None listed |
| Jan 6, 2016 | Biomet 3i, LLC BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655
BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placemen Terminated |
NDP | None listed |
| Jan 6, 2016 | Biomet 3i, LLC BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H
BIOMET 3i Restorative Products are intended for use as an accessory to endosseo Terminated |
NDP | None listed |
| Dec 31, 2015 | Biomet 3i, LLC Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants. Terminated |
NDP | None listed |
| Nov 12, 2015 | Biomet 3i, LLC Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal Terminated |
NDP | None listed |
| Nov 12, 2015 | Biomet 3i, LLC Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and Terminated |
NDP | None listed |
| Jul 15, 2015 | Nobel Biocare Usa Llc Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if t Terminated |
NDP | None listed |
| Feb 12, 2015 | Zimmer Dental Inc GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical K Terminated |
NDP | None listed |
| Jan 15, 2015 | Straumann USA, LLC Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set. Terminated |
NDP | None listed |
| Mar 20, 2013 | Keystone Dental Inc PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm
Catalog Number: l5613K.
Implants in support for fixed bridgework. Terminated |
NDP | K051614 |
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