Clearance Summary
PRECIOUS-METAL/PLASTIC ATTACH., AUXILL received FDA 510(k) clearance under submission number K812360, sponsored by Zl-Microdent-Attachments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1981-09-21.
- Submission: K812360
- Applicant / Sponsor: Zl-Microdent-Attachments
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3165
- Decision date: 1981-09-21
Classification & Regulation
This clearance is catalogued under FDA product code EGG and 21 CFR 872.3165, within the Dental review panel as a Class I device.