Clearance Summary
DISC NEEDLE SET #TX-8220 received FDA 510(k) clearance under submission number K823676, sponsored by Today'S Machining & Design, 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 1983-01-09.
- Submission: K823676
- Applicant / Sponsor: Today'S Machining & Design, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1983-01-09
Classification & Regulation
This clearance is catalogued under FDA product code EMI and 21 CFR 872.4565, within the Dental review panel as a Class I device.