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PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500

K070287 Class I Traditional
Decision Date
2007-02-12
Sponsor / Applicant
Photonic Optische Gerate GmbH & Cokg

Technical Specification

510(k) Submission ID K070287
Product Code EBA
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.4630
Decision Date 2007-02-12
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 received FDA 510(k) clearance under submission number K070287, sponsored by Photonic Optische Gerate GmbH & Cokg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-02-12.

Classification & Regulation

This clearance is catalogued under FDA product code EBA and 21 CFR 872.4630, within the Dental review panel as a Class I device.