MILLENNIUM

System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation

ENDO TECHNIC CORP.

The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Millennium.

Pre-market Notification Details

• Device ID: K990908
• 510k Number: K990908
• Device Name: MILLENNIUM
• Classification: System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
• Applicant: ENDO TECHNIC CORP. 981 CALLE AMANECER (MOVED FROM BOS/DO TO LA/DOS) San Clemente, CA 92673 -6212
• Contact: Andrew I Kimmel
• Correspondent: Andrew I Kimmel; ENDO TECHNIC CORP. 981 CALLE AMANECER (MOVED FROM BOS/DO TO LA/DOS) San Clemente, CA 92673 -6212
• Product Code: MXF
• CFR Regulation Number: 872.4120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-03-18
• Decision Date: 1999-05-27
• Summary: summary