The following data is part of a premarket notification filed by Exacta Dental Products, Inc. with the FDA for Fresh, Dental Impression Material.
| Device ID | K053427 |
| 510k Number | K053427 |
| Device Name: | FRESH, DENTAL IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | EXACTA DENTAL PRODUCTS, INC. 1151 HOPE STREET Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen EXACTA DENTAL PRODUCTS, INC. 1151 HOPE STREET Stamford, CT 06907 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-08 |
| Decision Date | 2006-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E239D5048741 | K053427 | 000 |
| E239HFPD01751 | K053427 | 000 |
| E239HFPD02871 | K053427 | 000 |
| E239HFPD02941 | K053427 | 000 |
| E239HFPD05191 | K053427 | 000 |
| E239D51001 | K053427 | 000 |
| E239D51031 | K053427 | 000 |
| E239D51061 | K053427 | 000 |
| E239D51071 | K053427 | 000 |
| E239D51211 | K053427 | 000 |
| E239D484111 | K053427 | 000 |
| E239D51141 | K053427 | 000 |
| E239HFPD01381 | K053427 | 000 |
| E239D916110051 | K053427 | 000 |
| E239D5048751 | K053427 | 000 |
| E239D5048761 | K053427 | 000 |
| E239D5048771 | K053427 | 000 |
| E239D507701601 | K053427 | 000 |
| E239D7485N1 | K053427 | 000 |
| E239D907110021 | K053427 | 000 |
| E239D907110031 | K053427 | 000 |
| E239D907170051 | K053427 | 000 |
| E239D907170061 | K053427 | 000 |
| E239D907170071 | K053427 | 000 |
| E239D916110041 | K053427 | 000 |
| E239D907130011 | K053427 | 000 |
| 00815619020420 | K053427 | 000 |
| 00815619020536 | K053427 | 000 |
| 00815619021298 | K053427 | 000 |
| 00815619021304 | K053427 | 000 |
| 00815619021311 | K053427 | 000 |
| 00815619021328 | K053427 | 000 |
| 00815619021335 | K053427 | 000 |
| 00815619021342 | K053427 | 000 |
| 00815619021359 | K053427 | 000 |
| 00815619021366 | K053427 | 000 |
| 00815619021373 | K053427 | 000 |
| 00815619021380 | K053427 | 000 |
| 00815619021397 | K053427 | 000 |
| 00815619021274 | K053427 | 000 |
| 00815619021267 | K053427 | 000 |
| 00815619020550 | K053427 | 000 |
| 00815619020567 | K053427 | 000 |
| 00815619020574 | K053427 | 000 |
| 00815619020581 | K053427 | 000 |
| 00815619020598 | K053427 | 000 |
| 00815619020604 | K053427 | 000 |
| 00815619020628 | K053427 | 000 |
| 00815619020871 | K053427 | 000 |
| 00815619020888 | K053427 | 000 |
| 00815619021120 | K053427 | 000 |
| 00815619021137 | K053427 | 000 |
| 00815619021403 | K053427 | 000 |