ClearanceBrief
Panels › Dental › Product code NDP · Class 1

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)
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Top companies in NDP

DateFirm and productCodeLinked 510(k)
Feb 9, 2026Straumann USA LLC
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Open, Classified
NDPNone listed
Aug 25, 2025Dentsply 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
NDPNone listed
Aug 25, 2025Dentsply 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
NDPNone listed
May 28, 2025Prismatik 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
NDPNone listed
Apr 14, 2025Straumann USA LLC
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Open, Classified
NDPNone listed
Mar 11, 2025TruAbutment 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
NDPNone listed
Aug 19, 2024Preat 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
NDPNone listed
Mar 20, 2024Thommen Medical AG
impression coping, repositionable, short, screw-retained, PF 4.0
Open, Classified
NDPNone listed
Jul 26, 2021Paltop 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
NDPNone listed
Jul 26, 2021Paltop 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
NDPNone listed
Jul 26, 2021Paltop 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
NDPNone listed
Jul 26, 2021Paltop 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
NDPNone listed
Jul 26, 2021Paltop 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
NDPNone listed
Jul 26, 2021Paltop 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
NDPNone listed
May 27, 2021Straumann USA LLC
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Terminated
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Apr 3, 2019Thommen 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
NDPNone listed
Nov 28, 2018Implant 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
NDPNone listed
Nov 28, 2018Implant 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
NDPNone listed
Sep 6, 2018Implant 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
NDPNone listed
May 29, 2018Implant 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
NDPNone listed
Jan 24, 2018Keystone 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
NDPNone listed
Nov 15, 2017Implant 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
NDPNone listed
Oct 11, 2017Zimmer 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
NDPNone listed
Oct 11, 2017Zimmer 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
NDPNone listed
Oct 11, 2017Zimmer 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
NDPNone listed
Oct 11, 2017Zimmer 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
NDPNone listed
Jul 10, 2017Zimmer 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
NDPNone listed
Jul 10, 2017Zimmer 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
NDPNone listed
Jul 10, 2017Zimmer 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
NDPNone listed
Jul 10, 2017Zimmer Dental Inc
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Terminated
NDPNone listed
Apr 7, 2017Instradent USA, Inc.
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Terminated
NDPNone listed
Nov 23, 2016Straumann 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
NDPNone listed
Nov 23, 2016Straumann 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
NDPNone listed
Jan 6, 2016Biomet 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
NDPNone listed
Jan 6, 2016Biomet 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
NDPNone listed
Dec 31, 2015Biomet 3i, LLC
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Terminated
NDPNone listed
Nov 12, 2015Biomet 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
NDPNone listed
Nov 12, 2015Biomet 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
NDPNone listed
Jul 15, 2015Nobel 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
NDPNone listed
Feb 12, 2015Zimmer 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
NDPNone listed
Jan 15, 2015Straumann USA, LLC
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
Terminated
NDPNone listed
Mar 20, 2013Keystone Dental Inc
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Terminated
NDPK051614

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