NOVEL PRINT CYAN ALGINATES

Material, Impression

MANUFACTURERA DENTAL CONTINENTAL

The following data is part of a premarket notification filed by Manufacturera Dental Continental with the FDA for Novel Print Cyan Alginates.

Pre-market Notification Details

• Device ID: K011785
• 510k Number: K011785
• Device Name: NOVEL PRINT CYAN ALGINATES
• Classification: Material, Impression
• Applicant: MANUFACTURERA DENTAL CONTINENTAL 27881 LA PAZ ROAD, #G 316 Laguna Niguel, CA 92677
• Contact: Gary S Mocnik
• Correspondent: Gary S Mocnik; MANUFACTURERA DENTAL CONTINENTAL 27881 LA PAZ ROAD, #G 316 Laguna Niguel, CA 92677
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-06-08
• Decision Date: 2001-09-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07506338321754	K011785	000
07506338304153	K011785	000
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