Clearance Summary
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING received FDA 510(k) clearance under submission number K981881, sponsored by Doctor'S Research Group, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-12-02.
- Submission: K981881
- Applicant / Sponsor: Doctor'S Research Group, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 1998-12-02
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.