Recall Z-0154-2024— Preat Corp
Class II · Ongoing
Class II FDA medical device recall by Preat Corp, initiated 2023-07-18. It names one FDA 510(k) clearance: K220823. Product: Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental. Reason: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage.
- Recalling firm
- Preat Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-18
- Firm location
- Santa Maria, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Reason for recall
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Data sourced from openFDA. This site is unofficial and independent of the FDA.