Clearance Summary
PROBE TIP/PERI PROBE/PERI PROBE COMP. received FDA 510(k) clearance under submission number K936221, sponsored by Pd International AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-08-01.
- Submission: K936221
- Applicant / Sponsor: Pd International AB
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-08-01
Classification & Regulation
This clearance is catalogued under FDA product code EIX and 21 CFR 872.4565, within the Dental review panel as a Class I device.