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) |
|---|---|---|---|
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE 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 inte Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN 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 a Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN 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 inte Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(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 3.4MM(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 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H)
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 CERTAIN LOW PROFILE 30 ABUTMENT 4.1MM(D) X 5MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN 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 i Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN 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 i Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN 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 i Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN 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 i Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 4MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i CERTAIN LOW PROFILE 17 ABUTMENT 3.4MM(D) X 2MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is i Terminated |
NHA | K092341 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue 15 degree Angled Post
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue Post
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue 15 degree Pre- Angled Post
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Twist Lock TM Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Pick-Up Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Conical Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Conical 25 degree Angled Abutment
Dental implants Terminated |
NHA | K063403 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Conical 17 degree Angled Abutment
Dental implants Terminated |
NHA | K063403 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Bellatek Encode Healing Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Twist Lock TM Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Bellatek Encode Healing Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H)
Item: ITHA52
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Conical Abutment Pick-up Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Conical Abutment Gold Standard ZR TM
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Conical Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Conical 25 degree Angled Abutment
Dental implants Terminated |
NHA | K063403 |
| Aug 12, 2016 | Biomet 3i, LLC Conical 17 degree Angled Abutment
Dental implants Terminated |
NHA | K063403 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Twist Lock TM Coping
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Twist Lock TM Straight Transfer Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Twist Lock TM Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Temporary Non-Hexed Cylinder
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Temporary Hexed Cylinder
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Straight Pick Up Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Straight Healing Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Standard Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Provide Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Preformance Temporary Cylinder
Dental implants Terminated |
NHA | K060291 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Preformance Post
Dental implants Terminated |
NHA | K053170 K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Preformance 15 degrees Pre-Angled Post
Dental implants Terminated |
NHA | K053170 K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Pick-up Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Non-Hexed Implant Pick-up Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain IOL Abutment
Dental implants Terminated |
NHA | K072642 |
| Aug 12, 2016 | Biomet 3i, LLC Certain Implant EP Twist Lock TM Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Hex Try-in Screw (5 pk)
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Abutment Impression Coping
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC IOL Transfer Impression Coping
Dental implants Terminated |
NHA | None listed |
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