INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
FDA 510(k) clearance K142115 · decided 2014-11-13
Clearance details
- K-number
- K142115
- Device name
- INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
- Applicant
- Prismatik Dentalcraft, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-04
- Decision date
- 2014-11-13
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" C recall (Z-0417-2026) | Prismatik Dentalcraft, Inc. | 2025-11-03 |