The following data is part of a premarket notification filed by Bioloren Srl with the FDA for Fiber Disk And Block Permanent, Trinia.
| Device ID | K121735 |
| 510k Number | K121735 |
| Device Name: | FIBER DISK AND BLOCK PERMANENT, TRINIA |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BIOLOREN SRL VIA ALESSANDRO VOLTA 59 Saronno, Va, IT 21047 |
| Contact | Ratti Andrea |
| Correspondent | Ratti Andrea BIOLOREN SRL VIA ALESSANDRO VOLTA 59 Saronno, Va, IT 21047 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-13 |
| Decision Date | 2013-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056099230394 | K121735 | 000 |
| 08056099230219 | K121735 | 000 |
| 08056099230202 | K121735 | 000 |
| 08056099230196 | K121735 | 000 |
| 08056099230189 | K121735 | 000 |
| 08056099230172 | K121735 | 000 |
| 08056099230165 | K121735 | 000 |
| 08056099230158 | K121735 | 000 |
| 08056099230141 | K121735 | 000 |
| 08056099230134 | K121735 | 000 |
| 08056099230127 | K121735 | 000 |
| 08056099230110 | K121735 | 000 |
| 08056099230103 | K121735 | 000 |
| 08056099230097 | K121735 | 000 |
| 08056099230080 | K121735 | 000 |
| 08056099230226 | K121735 | 000 |
| 08056099230233 | K121735 | 000 |
| 08056099230240 | K121735 | 000 |
| 08056099230387 | K121735 | 000 |
| 08056099230370 | K121735 | 000 |
| 08056099230363 | K121735 | 000 |
| 08056099230356 | K121735 | 000 |
| 08056099230349 | K121735 | 000 |
| 08056099230332 | K121735 | 000 |
| 08056099230325 | K121735 | 000 |
| 08056099230318 | K121735 | 000 |
| 08056099230301 | K121735 | 000 |
| 08056099230295 | K121735 | 000 |
| 08056099230288 | K121735 | 000 |
| 08056099230271 | K121735 | 000 |
| 08056099230264 | K121735 | 000 |
| 08056099230257 | K121735 | 000 |
| 08056099230073 | K121735 | 000 |