TEM-STIK

Cement, Dental

CORALITE DENTAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Coralite Dental Products, Inc. with the FDA for Tem-stik.

Pre-market Notification Details

• Device ID: K821824
• 510k Number: K821824
• Device Name: TEM-STIK
• Classification: Cement, Dental
• Applicant: CORALITE DENTAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-06-22
• Decision Date: 1982-07-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850015110337	K821824	000