ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS
FDA 510(k) clearance K934126 · decided 1994-04-25
Clearance details
- K-number
- K934126
- Device name
- ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS
- Applicant
- Implant Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-25
- Decision date
- 1994-04-25
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Palm Baeach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Provide Protection Cap Dental implants recall (Z-2441-2016) | Biomet 3i, LLC | 2016-08-12 |
| BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i recall (Z-0591-2016) | Biomet 3i, LLC | 2016-01-06 |
| BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4 recall (Z-0592-2016) | Biomet 3i, LLC | 2016-01-06 |
| "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment recall (Z-2799-2011) | Biomet 3i, LLC | 2011-07-13 |
| EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly recall (Z-0922-2007) | Biomet 3i | 2007-06-14 |
| Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, recall (Z-0811-2007) | Biomet 3i | 2007-05-16 |
| EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly recall (Z-0029-05) | Implant Innovations, Inc. | 2004-10-21 |