510(k) K072642 ยท NHA Abutment, Implant, Dental, Endosseous
BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
| Applicant | Biomet 3i, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Dec 20, 2007 |
| Received | Sep 18, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
Reference Number: IEHA454 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H)
Reference Number: IEHA456 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H)
Reference Number: IEHA463 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA464 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H)
Reference Number: IEHA466 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H)
Reference Number: IEHA474 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H)
Reference Number: IEHA553 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H)
Reference Number: IEHA554 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H)
Reference Number: IEHA563 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA564 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA564 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H)
Reference Number: IEHA566 Terminated |
NHA | None listed |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number:
IEHA574 Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H)
Item: IWTH52
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H)
Item: IWTH54
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H)
Item: IMPAP32G
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H)
Item: IPAP454G.
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H)
Item: IWPP552G
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H)
Item: IMAP32G
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H)
Item: IAPP454G
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Pick-Up Coping 5mm(D) x 5mm(P)
Item:IWIP55
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H)
Item:ISHA44
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H)
Item: PAP452G
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Gold-Tite Hexed Retaining Screw 3mm
Item: GSH30
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Gold-Tite Square Uniscrew
Item: UNISG
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Preformance 15 degrees pre-angled post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Prep-Tite Post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Standard Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Standard Abutment Temporary Screw
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Temporary Healing Retention Cylinder
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Temporary Hexed Cylinder
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Temporary Non-Hexed Cylinder
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Titanium Hexed Uniscrew
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Titanium Square Uniscrew
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Conical EP Healing Cap
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Conical Healing Cap
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Gingihue 15 Degree Pre-Angled Post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Gingihue Post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Gold Slotted Screw
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Gold -Tite Hexed Retaining Screw
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Healing Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC IOL Abutment and Screw
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC IOL Distal Extension
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC IOL Healing Cap
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC IOL Titanium Temporary Cylinder
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain IOL Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Preformance 15 degrees Pre-Angled Post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Preformance Post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Provide Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Standard Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Straight Healing Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Temporary Hexed Cylinder
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Temporary Non-Hexed Cylinder
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 Conical Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Conical Abutment Gold Standard ZR TM
Dental implants Terminated |
NHA | None listed |
| 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 | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Bellatek Encode Healing Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Bellatek Encode Healing Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Conical Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain EP Healing Abutment
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue 15 degree Pre- Angled Post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue Post
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue 15 degree Angled Post
Dental implants Terminated |
NHA | None listed |
| Sep 11, 2015 | Biomet 3i, LLC UCLA Abutment Hexed Castable Cylinder 3.4mm
Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. Terminated |
NHA | None listed |
| Sep 5, 2014 | Biomet 3i, LLC BIOMET 3i Certain Bellatek Encode Healing Abutment
Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior t Terminated |
NHA | None listed |
| Nov 3, 2011 | Biomet 3i, LLC "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX On Terminated |
NHA | None listed |
| Sep 22, 2009 | Biomet 3i, LLC 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410.
Custom tempo Terminated |
NDA | None listed |
| Mar 29, 2008 | Biomet 3i, Inc. BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL Terminated |
NHA | None listed |
| Mar 28, 2008 | Biomet 3i, Inc. BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL. Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.