MILLENNIUM

Handpiece, Air-powered, Dental

BIOLASE TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Millennium.

Pre-market Notification Details

• Device ID: K980585
• 510k Number: K980585
• Device Name: MILLENNIUM
• Classification: Handpiece, Air-powered, Dental
• Applicant: BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673
• Contact: Andrew I Kimmel
• Correspondent: Andrew I Kimmel; BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673
• Product Code: EFB
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-02-17
• Decision Date: 1998-10-08
• Summary: summary