Clearance Summary
ANALYTIC TECH. METAL POINT HEATER #3001 received FDA 510(k) clearance under submission number K801974, sponsored by Analytic Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-11-12.
- Submission: K801974
- Applicant / Sponsor: Analytic Technology
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1980-11-12
Classification & Regulation
This clearance is catalogued under FDA product code ELA and 21 CFR 872.4565, within the Dental review panel as a Class I device.