Clearance Summary
HYGIENIC 5 & 6 RUBBER DAM FRAME received FDA 510(k) clearance under submission number K770117, sponsored by Hygienic Dental Mfg., Co., The. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-01-28.
- Submission: K770117
- Applicant / Sponsor: Hygienic Dental Mfg., Co., The
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 1977-01-28
Classification & Regulation
This clearance is catalogued under FDA product code EJE and 21 CFR 872.6300, within the Dental review panel as a Class I device.