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AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV

K043497 Class I Traditional
Decision Date
2005-03-21
Sponsor / Applicant
J. Morita USA, Inc.

Technical Specification

510(k) Submission ID K043497
Product Code EFB
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.4200
Decision Date 2005-03-21
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV received FDA 510(k) clearance under submission number K043497, sponsored by J. Morita USA, 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 2005-03-21.

Classification & Regulation

This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.