Abutment, Implant, Dental, Endosseous
Regulation 872.3630
30510(k)s in 12 months (716 all time)
5recalls in 12 months (225 all time)
194recalls that name a 510(k)
Top companies in NHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet 3i | 19 | 174 |
| Nobel Biocare AB | 49 | 7 |
| Institut Straumann AG | 47 | 0 |
| Straumann USA | 32 | 7 |
| Dentsply Sirona | 23 | 0 |
| Terrats Medical SL | 21 | 0 |
| Zimmer Dental, Inc. | 21 | 0 |
| Prismatik Dentalcraft, Inc. | 19 | 1 |
| Osstem Implant Co., Ltd. | 18 | 0 |
| Atlantis Components, Inc. | 17 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)
Reference Number: IEHA453 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H)
Reference Number: IEHA446 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)
Reference Number: IEHA444 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)
Reference Number: IEHA443 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H)
Reference Number: IEHA356 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H)
Reference Number: IEHA354 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H)
Reference Number: IEHA353 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H)
Reference Number: IEHA346 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)
Reference Number: IEHA344 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H)
Reference Number: IEHA343 Terminated |
NHA | K072642 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are inte Terminated |
NHA | K161435 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be us Terminated |
NHA | K071370 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used Terminated |
NHA | K071370 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be Terminated |
NHA | K974150 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to b Terminated |
NHA | K974150 |
| Jul 19, 2019 | Nobel Biocare Usa Llc NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 Terminated |
NHA | K071370 |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the Terminated |
NHA | K052648 K102209 |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max Terminated |
NHA | K052648 K102209 |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th Terminated |
NHA | K052648 K102209 |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th Terminated |
NHA | K052648 K102209 |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max Terminated |
NHA | K052648 K102209 |
| Jul 23, 2018 | Nobel Biocare Usa Llc Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614.
Product Usage:
Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore che Terminated |
NHA | K072570 |
| Mar 8, 2018 | Southern Implants, (Pty.) Ltd. SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or Terminated |
NHA | K163634 |
| Jan 23, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform Terminated |
NHA | K130572 |
| Jan 19, 2018 | Implant Direct Sybron Manufacturing, LLC SwishPlus Implant
Intended for use in support for fixed bridgework. Terminated |
NHA | K081396 |
| Jul 21, 2017 | Implant Direct Sybron Manufacturing, LLC Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component. Terminated |
NHA | K090234 |
| Jun 20, 2017 | Keystone Dental Inc Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K
pRODUCT Usage:
Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple- Terminated |
NHA | K051614 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inten Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental impla Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inte Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use a Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental imp Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implan Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use a Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE 17 ABUTMENT 4.1MM(D) X 4MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE 30 ABUTMENT 4.1MM(D) X 3MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE 17 ABUTMENT 4.1MM(D) X 2MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE 30 ABUTMENT 3.4MM(D) X 5MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE 30 ABUTMENT 3.4MM(D) X 3MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant a Terminated |
NHA | K092341 |
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