The following data is part of a premarket notification filed by Exacta Dental Direct, Inc with the FDA for Fixtemp C&b.
| Device ID | K102917 |
| 510k Number | K102917 |
| Device Name: | FIXTEMP C&B |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | EXACTA DENTAL DIRECT, INC 1151 HOPE STREET Stamford, CT 06907 -1659 |
| Contact | Richard Keen |
| Correspondent | Richard Keen EXACTA DENTAL DIRECT, INC 1151 HOPE STREET Stamford, CT 06907 -1659 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-01 |
| Decision Date | 2011-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815619021175 | K102917 | 000 |
| 00815619021830 | K102917 | 000 |
| E239D507421A1X1S1 | K102917 | 000 |
| E239D507421A35X1S1 | K102917 | 000 |
| E239D507421A3X1S1 | K102917 | 000 |
| E239D507421B1X1S1 | K102917 | 000 |
| E239D507421BX1S1 | K102917 | 000 |
| E239D507421C2X1S1 | K102917 | 000 |
| E239D507421X1S1 | K102917 | 000 |
| E239D503931 | K102917 | 000 |
| 00815619020451 | K102917 | 000 |
| 00815619020468 | K102917 | 000 |
| 00815619021168 | K102917 | 000 |
| 00815619021809 | K102917 | 000 |