The following data is part of a premarket notification filed by Exacta Dental Direct, Inc with the FDA for Fixtemp Cement.
| Device ID | K142446 |
| 510k Number | K142446 |
| Device Name: | Fixtemp Cement |
| Classification | Cement, Dental |
| Applicant | EXACTA DENTAL DIRECT, INC 44780 MACOMB INDUSTRIAL DR., Clinton Township, MI 48036 |
| Contact | John Pankuch |
| Correspondent | Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907 -1659 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-02 |
| Decision Date | 2015-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239D5039311 | K142446 | 000 |
| E239D7433S1 | K142446 | 000 |
| E239D5074331 | K142446 | 000 |