The following data is part of a premarket notification filed by Bioloren Srl with the FDA for Fiber Disk And Block.
| Device ID | K112186 |
| 510k Number | K112186 |
| Device Name: | FIBER DISK AND BLOCK |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | BIOLOREN SRL VIA ALESSANDRO VOLTA 59 Saronno, IT |
| Contact | Andrea Ratti |
| Correspondent | Andrea Ratti BIOLOREN SRL VIA ALESSANDRO VOLTA 59 Saronno, IT |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-29 |
| Decision Date | 2011-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056099230721 | K112186 | 000 |
| 08056099230547 | K112186 | 000 |
| 08056099230530 | K112186 | 000 |
| 08056099230523 | K112186 | 000 |
| 08056099230516 | K112186 | 000 |
| 08056099230509 | K112186 | 000 |
| 08056099230493 | K112186 | 000 |
| 08056099230486 | K112186 | 000 |
| 08056099230479 | K112186 | 000 |
| 08056099230462 | K112186 | 000 |
| 08056099230455 | K112186 | 000 |
| 08056099230448 | K112186 | 000 |
| 08056099230431 | K112186 | 000 |
| 08056099230424 | K112186 | 000 |
| 08056099230417 | K112186 | 000 |
| 08056099230554 | K112186 | 000 |
| 08056099230561 | K112186 | 000 |
| 08056099230578 | K112186 | 000 |
| 08056099230714 | K112186 | 000 |
| 08056099230707 | K112186 | 000 |
| 08056099230691 | K112186 | 000 |
| 08056099230684 | K112186 | 000 |
| 08056099230677 | K112186 | 000 |
| 08056099230660 | K112186 | 000 |
| 08056099230653 | K112186 | 000 |
| 08056099230646 | K112186 | 000 |
| 08056099230639 | K112186 | 000 |
| 08056099230622 | K112186 | 000 |
| 08056099230615 | K112186 | 000 |
| 08056099230608 | K112186 | 000 |
| 08056099230592 | K112186 | 000 |
| 08056099230585 | K112186 | 000 |
| 08056099230400 | K112186 | 000 |