Clearance Summary
TS-301 THREE-WAY PULP TESTER received FDA 510(k) clearance under submission number K800138, sponsored by Tamler-Stoneham Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-02-13.
- Submission: K800138
- Applicant / Sponsor: Tamler-Stoneham Instruments
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1720
- Decision date: 1980-02-13
Classification & Regulation
This clearance is catalogued under FDA product code EAT and 21 CFR 872.1720, within the Dental review panel as a Class II device.