Clearance Summary
Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw received FDA 510(k) clearance under submission number K231100, sponsored by Proimtech Saglik Urunleri Anonim Sirketi. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-08-23.
- Submission: K231100
- Applicant / Sponsor: Proimtech Saglik Urunleri Anonim Sirketi
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2024-08-23
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.