The following data is part of a premarket notification filed by Silicon-und Composite Spezialitaten Gmbh with the FDA for Prov-kb.
Device ID | K960938 |
510k Number | K960938 |
Device Name: | PROV-KB |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | SILICON-UND COMPOSITE SPEZIALITATEN GMBH OFFENAUER WEG 19 Bokholt-hanredder, DE D-25335 |
Contact | Jurgen Engelbrecht |
Correspondent | Jurgen Engelbrecht SILICON-UND COMPOSITE SPEZIALITATEN GMBH OFFENAUER WEG 19 Bokholt-hanredder, DE D-25335 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-08 |
Decision Date | 1996-04-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00813277020219 | K960938 | 000 |
00813277020202 | K960938 | 000 |