ACCLAIM

Unit, Operative Dental, Accessories

AIR TECHNIQUES, INC.

The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Acclaim.

Pre-market Notification Details

• Device ID: K042266
• 510k Number: K042266
• Device Name: ACCLAIM
• Classification: Unit, Operative Dental, Accessories
• Applicant: AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11801
• Contact: Joseph Carey
• Correspondent: Joseph Carey; AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11801
• Product Code: NRD
• CFR Regulation Number: 872.6640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-23
• Decision Date: 2004-08-31