Device product

Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

Z-0154-2024

July 18, 2023

Class II

Product summary

Firm: Preat Corp
Event: Event 92867
Status: Ongoing
Classification: Class II
Quantity: 4 units
Official record key: device-enforcement:Z-0154-2024

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: 00842092161395/Lot #OF018355

Distribution pattern: US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage