Clearance Summary
DOUBLE BOW TOOTH SEPARATOR received FDA 510(k) clearance under submission number K831136, sponsored by Almore Intl., 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 1983-06-08.
- Submission: K831136
- Applicant / Sponsor: Almore Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1983-06-08
Classification & Regulation
This clearance is catalogued under FDA product code JEP and 21 CFR 872.4565, within the Dental review panel as a Class I device.