The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio Blocs.
| Device ID | K171200 |
| 510k Number | K171200 |
| Device Name: | Grandio Blocs |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Contact | M. Th. Plaumann |
| Correspondent | T. Gerkensmeier VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22161530 | K171200 | 000 |
| E221617130 | K171200 | 000 |
| E22161740 | K171200 | 000 |
| E22161770 | K171200 | 000 |
| E22161780 | K171200 | 000 |
| E22161790 | K171200 | 000 |
| E22161800 | K171200 | 000 |
| E22161830 | K171200 | 000 |
| E22161840 | K171200 | 000 |
| E22160031 | K171200 | 000 |
| E22160041 | K171200 | 000 |
| E22160051 | K171200 | 000 |
| E22160061 | K171200 | 000 |
| E221617120 | K171200 | 000 |
| E22161710 | K171200 | 000 |
| E22161700 | K171200 | 000 |
| E22161540 | K171200 | 000 |
| E22161550 | K171200 | 000 |
| E22161560 | K171200 | 000 |
| E22161570 | K171200 | 000 |
| E22161580 | K171200 | 000 |
| E22161590 | K171200 | 000 |
| E22161620 | K171200 | 000 |
| E22161630 | K171200 | 000 |
| E22161640 | K171200 | 000 |
| E22161650 | K171200 | 000 |
| E22161680 | K171200 | 000 |
| E22161690 | K171200 | 000 |
| E22160071 | K171200 | 000 |
| E22160081 | K171200 | 000 |
| E22160091 | K171200 | 000 |
| E22160331 | K171200 | 000 |
| E22160341 | K171200 | 000 |
| E22160501 | K171200 | 000 |
| E22160511 | K171200 | 000 |
| E22160521 | K171200 | 000 |
| E22160531 | K171200 | 000 |
| E22160541 | K171200 | 000 |
| E22160551 | K171200 | 000 |
| E22160561 | K171200 | 000 |
| E22160571 | K171200 | 000 |
| E22160581 | K171200 | 000 |
| E22160591 | K171200 | 000 |
| E22160301 | K171200 | 000 |
| E22160291 | K171200 | 000 |
| E22160281 | K171200 | 000 |
| E22160121 | K171200 | 000 |
| E22160131 | K171200 | 000 |
| E22160141 | K171200 | 000 |
| E22160151 | K171200 | 000 |
| E22160181 | K171200 | 000 |
| E22160191 | K171200 | 000 |
| E22160201 | K171200 | 000 |
| E22160211 | K171200 | 000 |
| E22160221 | K171200 | 000 |
| E22160231 | K171200 | 000 |
| E22160241 | K171200 | 000 |
| E22160271 | K171200 | 000 |
| E22160601 | K171200 | 000 |