TEMPIT

Cement, Dental

CENTRIX, INC.

The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Tempit.

Pre-market Notification Details

• Device ID: K931084
• 510k Number: K931084
• Device Name: TEMPIT
• Classification: Cement, Dental
• Applicant: CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458
• Contact: John Discko
• Correspondent: John Discko; CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-03-02
• Decision Date: 1993-05-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817051020013	K931084	000