PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL

Material, Tooth Shade, Resin

PRIME DENTAL MANUFACTURING, INC.

The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent Automix Dual Cure Core Build Up Material.

Pre-market Notification Details

• Device ID: K022675
• 510k Number: K022675
• Device Name: PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
• Classification: Material, Tooth Shade, Resin
• Applicant: PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618
• Contact: Rolando Marasigan
• Correspondent: Rolando Marasigan; PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago, IL 60618
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-08-12
• Decision Date: 2002-11-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817441023556	K022675	000
D77819930701	K022675	000
D77819930651	K022675	000
D77819930611	K022675	000
D77819930601	K022675	000