The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Futurabond Nr.
Device ID | K042670 |
510k Number | K042670 |
Device Name: | FUTURABOND NR |
Classification | Agent, Tooth Bonding, 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 | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-29 |
Decision Date | 2004-11-01 |