The following data is part of a premarket notification filed by Silmet U.s.a. Corp. with the FDA for High-q-bond.
| Device ID | K933766 |
| 510k Number | K933766 |
| Device Name: | HIGH-Q-BOND |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SILMET U.S.A. CORP. 18968 N.E. 4TH CT. North Miami Beach, FL 33179 |
| Contact | Bruce Richman |
| Correspondent | Bruce Richman SILMET U.S.A. CORP. 18968 N.E. 4TH CT. North Miami Beach, FL 33179 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00348783000689 | K933766 | 000 |
| 07290115050158 | K933766 | 000 |
| 07290115050370 | K933766 | 000 |
| 07290115050448 | K933766 | 000 |
| 07290115050462 | K933766 | 000 |
| 07290115050479 | K933766 | 000 |
| 07290115052886 | K933766 | 000 |
| 00348783000641 | K933766 | 000 |
| 00348783000658 | K933766 | 000 |
| 00348783000665 | K933766 | 000 |
| 07290115050141 | K933766 | 000 |