The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Structur 2 Sc.
| Device ID | K040769 |
| 510k Number | K040769 |
| Device Name: | STRUCTUR 2 SC |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-25 |
| Decision Date | 2004-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051021300 | K040769 | 000 |
| 00817051021294 | K040769 | 000 |
| 00817051021287 | K040769 | 000 |