ClearanceBrief
Panels › Dental › Product code DZE · Class 2

Implant, Endosseous, Root-Form

Regulation 872.3640

20510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
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Top companies in DZE

DateFirm and productCodeLinked 510(k)
Sep 15, 2026Straumann USA LLC
GM Helix Implant, REF: 109.984;
Open, Classified
DZEK163194
Aug 11, 2026Straumann USA LLC
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Open, Classified
DZEK140878
Oct 1, 2025S.I.N. Implant System Ltda
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, RE
Open, Classified
DZENone listed
May 28, 2025Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.985
Open, Classified
DZEK163194
May 28, 2025Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.984
Open, Classified
DZEK163194
Feb 5, 2025Nobel Biocare
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endoss
Open, Classified
DZEK211109
Jan 15, 2025SIN SISTEMA DE IMPLANTE NACIONAL S.A
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Open, Classified
DZEK222231
May 18, 2023Hiossen Inc.
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Open, Classified
DZEK151626
Aug 23, 2022Nobel Biocare
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Open, Classified
DZEK211109
Dec 17, 2021Nobel Biocare Usa Llc
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Terminated
DZEK073142
Nov 30, 2021Straumann USA LLC
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Terminated
DZEK203382
Nov 30, 2021Straumann USA LLC
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Terminated
DZEK203382
Oct 11, 2021Jjgc Industria E Comercio De Materials Dentarios Sa
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Terminated
DZEK163194
Sep 23, 2021Implant Direct Sybron Manufacturing LLC
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Open, Classified
DZEK192221
Sep 23, 2021Implant Direct Sybron Manufacturing LLC
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Open, Classified
DZEK192221
Jul 20, 2020NOBEL BIOCARE SERVICES AG
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supportin
Terminated
DZEK073142
May 4, 2020Nobel Biocare Usa Llc
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw b
Terminated
DZEK173418
Feb 19, 2020Nobel Biocare Usa Llc
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Terminated
DZEK955697
Feb 19, 2020Nobel Biocare Usa Llc
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants
Terminated
DZEK030685
Feb 5, 2020Implant Direct Sybron Manufacturing LLC
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Terminated
DZEK090234
Feb 4, 2020Implant Direct Sybron Manufacturing LLC
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Terminated
DZEK090234
Nov 22, 2019Zest Anchors LLC
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Open, Classified
DZEK120198
Nov 18, 2019Paltop Advanced Dental Solutions Ltd
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Terminated
DZEK130462
Nov 12, 2019Implant Direct Sybron Manufacturing, LLC
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Terminated
DZEK090234
Aug 9, 2019Nobel Biocare Usa Llc
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained
Terminated
DZEK925762
May 30, 2019Paltop Advanced Dental Solutions Ltd
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Terminated
DZEK112795
May 28, 2019Nobel Biocare Usa Llc
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting
Terminated
DZEK071370
Feb 22, 2019Keystone Dental Inc
Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
Terminated
DZEK112795
Feb 22, 2019Keystone Dental Inc
Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
Terminated
DZEK112795
Feb 22, 2019Keystone Dental Inc
Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
Terminated
DZEK112795
Feb 22, 2019Keystone Dental Inc
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
Terminated
DZEK112795
Oct 26, 2018Implant Direct Sybron Manufacturing, LLC
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Terminated
DZEK130572
Oct 2, 2018Straumann Manufacturing, Inc.
Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a
Terminated
DZEK163194
Aug 8, 2018Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the
Terminated
DZEK090234
Aug 7, 2018Implant Direct Sybron Manufacturing, LLC
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Terminated
DZEK061319
May 18, 2018Implant Direct Sybron Manufacturing, LLC
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Terminated
DZEK061319
May 10, 2018Zimmer Dental Inc
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Impl
Terminated
DZEK111889
May 1, 2018Keystone Dental Inc
Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit res
Terminated
DZEK051614
Mar 14, 2018Implant Direct Sybron Manufacturing, LLC
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Den
Terminated
DZEK130572
Mar 13, 2018Keystone Dental Inc
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Terminated
DZEK101545
Mar 5, 2018Zimmer Dental Inc
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Terminated
DZEK072589
Mar 5, 2018Zimmer Dental Inc
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Terminated
DZEK101977
Jan 19, 2018Implant Direct Sybron Manufacturing, LLC
SwishTapered Implant Intended for use in support for fixed bridgework.
Terminated
DZEK090234
Nov 20, 2017Zimmer Dental Inc
Tapered Screw-Vent MTX Model TSVTB11
Terminated
DZEK101977
Oct 16, 2017Keystone Dental Inc
STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Terminated
DZEK072768
Oct 10, 2017Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and
Terminated
DZEK090234
Aug 25, 2017Keystone Dental Inc
Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multip
Terminated
DZEK072768
Jul 10, 2017Zimmer Dental Inc
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3
Terminated
DZEK052997
K071235
Jul 10, 2017Zimmer Dental Inc
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G
Terminated
DZEK011028
K013227
Jun 16, 2017Keystone Dental Inc
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and
Terminated
DZEK071161

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