ENAMEL PRO

Agent, Polishing, Abrasive, Oral Cavity

PREMIER DENTAL PRODUCTS CO.

The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Enamel Pro.

Pre-market Notification Details

• Device ID: K062166
• 510k Number: K062166
• Device Name: ENAMEL PRO
• Classification: Agent, Polishing, Abrasive, Oral Cavity
• Applicant: PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462
• Contact: Vince D'alessandro
• Correspondent: Vince D'alessandro; PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462
• Product Code: EJR
• CFR Regulation Number: 872.6030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-28
• Decision Date: 2006-11-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00348783005400	K062166	000
00348783005257	K062166	000
00348783005240	K062166	000
00348783005233	K062166	000
00348783005226	K062166	000
00348783005219	K062166	000
00348783005202	K062166	000
00348783005196	K062166	000
00348783005189	K062166	000
00348783005172	K062166	000
00348783005165	K062166	000
00348783005158	K062166	000
00348783005264	K062166	000
00348783005271	K062166	000
00348783005394	K062166	000
00348783005387	K062166	000
00348783005370	K062166	000
00348783005363	K062166	000
00348783005356	K062166	000
00348783005349	K062166	000
00348783005332	K062166	000
00348783005325	K062166	000
00348783005318	K062166	000
00348783005295	K062166	000
00348783005288	K062166	000
00348783012989	K062166	000