AIRLIGHT DENTAL HANDPIECE

Handpiece, Air-powered, Dental

BEYES DENTAL CANADA INC

The following data is part of a premarket notification filed by Beyes Dental Canada Inc with the FDA for Airlight Dental Handpiece.

Pre-market Notification Details

• Device ID: K112623
• 510k Number: K112623
• Device Name: AIRLIGHT DENTAL HANDPIECE
• Classification: Handpiece, Air-powered, Dental
• Applicant: BEYES DENTAL CANADA INC 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901
• Contact: Anthony Hopkins
• Correspondent: Anthony Hopkins; BEYES DENTAL CANADA INC 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901
• Product Code: EFB
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-08
• Decision Date: 2011-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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