The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent Dual Cure Composite Luting Cement.
Device ID | K112574 |
510k Number | K112574 |
Device Name: | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT |
Classification | Cement, Dental |
Applicant | PRIME DENTAL MANUFACTURING, INC. 4555 WEST ADDISON STREET Chicago, IL 60641 |
Contact | Javier Alvarez |
Correspondent | Javier Alvarez PRIME DENTAL MANUFACTURING, INC. 4555 WEST ADDISON STREET Chicago, IL 60641 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-06 |
Decision Date | 2012-01-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810152820070 | K112574 | 000 |