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

Handpiece, Air-powered, Dental

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for 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.

Pre-market Notification Details

• Device ID: K043497
• 510k Number: K043497
• Device Name: 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
• Classification: Handpiece, Air-powered, Dental
• Applicant: J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005
• Contact: Keith A Barritt
• Correspondent: Keith A Barritt; J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005
• Product Code: EFB
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-12-17
• Decision Date: 2005-03-21
• Summary: summary