510(k) K142115 ยท NHA Abutment, Implant, Dental, Endosseous
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 13, 2014 |
| Received | Aug 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2025 | Prismatik Dentalcraft, Inc. Brand Name: Inclusive
Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm
Model/Catalog Number: 70-1047-COM0117 Open, Classified |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.