The following data is part of a premarket notification filed by Voco Gmbh with the FDA for N-hybride-composite Lc.
Device ID | K113563 |
510k Number | K113563 |
Device Name: | N-HYBRIDE-COMPOSITE LC |
Classification | Material, Tooth Shade, Resin |
Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Contact | M.th. Plaumann |
Correspondent | M.th. Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-21 |
Decision Date | 2011-12-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D6620704115610 | K113563 | 000 |
D6620704115042 | K113563 | 000 |
D6620704115122 | K113563 | 000 |
D6620704115202 | K113563 | 000 |
D6620704115382 | K113563 | 000 |
D6620704115462 | K113563 | 000 |
D6620704115532 | K113563 | 000 |
D6620704114391 | K113563 | 000 |
D6620704114471 | K113563 | 000 |
D66207041145419 | K113563 | 000 |
D66207041146218 | K113563 | 000 |
D66207041147017 | K113563 | 000 |
D6620704114962 | K113563 | 000 |