The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Viscalor.
Device ID | K201307 |
510k Number | K201307 |
Device Name: | VisCalor |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-15 |
Decision Date | 2020-07-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E22161230 | K201307 | 000 |
E221610710 | K201307 | 000 |
E221610910 | K201307 | 000 |
E22161101 | K201307 | 000 |
E22161130 | K201307 | 000 |
E22161140 | K201307 | 000 |
E22161150 | K201307 | 000 |
E22161160 | K201307 | 000 |
E22161170 | K201307 | 000 |
E22161180 | K201307 | 000 |
E22161190 | K201307 | 000 |
E22161200 | K201307 | 000 |
E22161210 | K201307 | 000 |
E22161220 | K201307 | 000 |
E22161060 | K201307 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VISCALOR 79255870 5929430 Live/Registered |
VOCO GmbH 2019-02-25 |