Clearance Summary
3D DENTAL DIAMOND ROTARY INSTRUMENTS received FDA 510(k) clearance under submission number K893844, sponsored by Lustgarten Multi-Tech International, 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 1989-08-11.
- Submission: K893844
- Applicant / Sponsor: Lustgarten Multi-Tech International, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4535
- Decision date: 1989-08-11
Classification & Regulation
This clearance is catalogued under FDA product code DZP and 21 CFR 872.4535, within the Dental review panel as a Class I device.