Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT# - Pft#
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093719 FDA 510(k)
- FDA Product Code
- DZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4880 FDA 510(k)
- Regulation Number
- 872.4880 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pro-Fix Precision Fixation System is a bone fixation device used to secure bone grafts or barrier membranes during oral bone regeneration procedures. It consists of screws and/or fixation devices that provide mechanical stabilization of graft materials to facilitate bone healing.
The device is supplied with an autoclavable storage tray that can store fixation instruments, membrane fixation, bone fixation, and tenting screws. It is used by dental clinicians in a clinical setting and is available in various models, including PFM#, PFB#, and PFT#. The device has been registered with the FDA under the product code DZL and regulation number 872.4880.
Frequently asked questions
What is the Pro-Fix Precision Fixation System used for?
The Pro-Fix Precision Fixation System is used to secure bone grafts or barrier membranes during oral bone regeneration procedures to facilitate bone healing.
How is the Pro-Fix Precision Fixation System supplied?
The device is supplied with an autoclavable storage tray that can store fixation instruments, membrane fixation, bone fixation, and tenting screws.
Is the Pro-Fix Precision Fixation System available in different models?
Yes, the device is available in various models, including PFM#, PFB#, and PFT#.
What is the regulatory classification of the Pro-Fix Precision Fixation System?
The device has been registered with the FDA under the product code DZL and regulation number 872.4880.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pro-fix™ Precision Fixation System - Bone Fixation - Osteogenics Biomedical, Pro-fix Precision Fixation System Model Pfm#, Pfb#, Pft# (K093719 ..., Pro-fix Precision Fixation System Model Pfm#, Pfb#, Pft#
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093719 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osteogenics Biomedical, Inc.
Sources (1)
- FDA 510(k) K093719 24 fields · synced Sep 23, 2026