The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Hy-bond Resiglass.
| Device ID | K111855 |
| 510k Number | K111855 |
| Device Name: | HY-BOND RESIGLASS |
| Classification | Cement, Dental |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-29 |
| Decision Date | 2011-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23532800 | K111855 | 000 |
| E2351212B0 | K111855 | 000 |
| E2351211B0 | K111855 | 000 |