Clearance Summary
MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) received FDA 510(k) clearance under submission number K864307, sponsored by Smith & Nephew, 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 1986-11-18.
- Submission: K864307
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1986-11-18
Classification & Regulation
This clearance is catalogued under FDA product code EIC and 21 CFR 872.4565, within the Dental review panel as a Class I device.