The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase And Contact.
| Device ID | K082560 |
| 510k Number | K082560 |
| Device Name: | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT |
| Classification | Material, Impression |
| Applicant | KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg, DE D-35713 |
| Contact | Michaela Zinke |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-04 |
| Decision Date | 2008-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004223345 | K082560 | 000 |
| E217111401 | K082560 | 000 |
| E217111411 | K082560 | 000 |
| E217111431 | K082560 | 000 |
| E217117811 | K082560 | 000 |
| E217118921 | K082560 | 000 |
| E217135011 | K082560 | 000 |
| E217147001 | K082560 | 000 |
| E217147011 | K082560 | 000 |
| E217147021 | K082560 | 000 |
| E217111231 | K082560 | 000 |
| E217111211 | K082560 | 000 |
| E217111201 | K082560 | 000 |
| 00850004223987 | K082560 | 000 |
| E21711781111 | K082560 | 000 |
| E21711892111 | K082560 | 000 |
| E21713501111 | K082560 | 000 |
| E217135051 | K082560 | 000 |
| E21713505111 | K082560 | 000 |
| E21728144111 | K082560 | 000 |
| 00850004223024 | K082560 | 000 |
| E217111011 | K082560 | 000 |
| E217147031 | K082560 | 000 |
| E217147041 | K082560 | 000 |
| 00883205027375 | K082560 | 000 |
| 00883205105257 | K082560 | 000 |
| 00883205105264 | K082560 | 000 |
| 00883205105295 | K082560 | 000 |
| 00883205105301 | K082560 | 000 |
| 00883205105318 | K082560 | 000 |
| 00883205105325 | K082560 | 000 |
| 00883205105332 | K082560 | 000 |
| 00883205105349 | K082560 | 000 |
| E22125641 | K082560 | 000 |
| E22125631 | K082560 | 000 |
| 00850004223000 | K082560 | 000 |
| E217147051 | K082560 | 000 |
| E217147061 | K082560 | 000 |
| E217147071 | K082560 | 000 |
| E217147081 | K082560 | 000 |
| E217147091 | K082560 | 000 |
| E217281261 | K082560 | 000 |
| E217281271 | K082560 | 000 |
| E217281441 | K082560 | 000 |
| E217281451 | K082560 | 000 |
| 00883205105363 | K082560 | 000 |