Device product
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Z-0153-2024
Product summary
- Firm
- Preat Corp
- Event
- Event 92867
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-0153-2024
Official wording
Reason: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Code information: UDI-DI: 00842092161388/Lot #OF018357
Distribution pattern: US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Derived failure modes
-
Unknown
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage