Clearance Summary
ACCUTEK PERIODONTAL PROBE received FDA 510(k) clearance under submission number K880827, sponsored by Sweet Micro Systems, 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 1988-04-12.
- Submission: K880827
- Applicant / Sponsor: Sweet Micro Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1988-04-12
Classification & Regulation
This clearance is catalogued under FDA product code EIX and 21 CFR 872.4565, within the Dental review panel as a Class I device.