The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Panasil Initial Contact And Panasil Tray.
| Device ID | K083701 |
| 510k Number | K083701 |
| Device Name: | PANASIL INITIAL CONTACT AND PANASIL TRAY |
| Classification | Material, Impression |
| Applicant | KETTENBACH GMBH & CO KG 975 VERONICA SPRINGS ROAD Santa Barbara, CA 93105 |
| Contact | Kristi Kistner |
| Correspondent | Kristi Kistner KETTENBACH GMBH & CO KG 975 VERONICA SPRINGS ROAD Santa Barbara, CA 93105 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E21713401111 | K083701 | 000 |
| E21728310111 | K083701 | 000 |
| E217134001 | K083701 | 000 |
| E217134011 | K083701 | 000 |
| E217134021 | K083701 | 000 |
| E217134101 | K083701 | 000 |
| E217134111 | K083701 | 000 |
| E217134121 | K083701 | 000 |
| E217134151 | K083701 | 000 |
| E217134301 | K083701 | 000 |
| E21728300111 | K083701 | 000 |
| E21713561111 | K083701 | 000 |
| E21713551111 | K083701 | 000 |
| E217134051 | K083701 | 000 |
| E21713405111 | K083701 | 000 |
| E21713411111 | K083701 | 000 |
| E21713415111 | K083701 | 000 |
| E21713431111 | K083701 | 000 |
| E21713461111 | K083701 | 000 |
| E21713471111 | K083701 | 000 |
| E21713541111 | K083701 | 000 |
| E21713545111 | K083701 | 000 |
| E217134311 | K083701 | 000 |
| E217134611 | K083701 | 000 |
| E217134631 | K083701 | 000 |
| E217135631 | K083701 | 000 |
| E217135651 | K083701 | 000 |
| E217283001 | K083701 | 000 |
| E217283101 | K083701 | 000 |
| E217S134001 | K083701 | 000 |
| E217S135601 | K083701 | 000 |
| 00883205027368 | K083701 | 000 |
| 00883205105240 | K083701 | 000 |
| 00883205105271 | K083701 | 000 |
| E217135611 | K083701 | 000 |
| E217135551 | K083701 | 000 |
| E217135531 | K083701 | 000 |
| E217134711 | K083701 | 000 |
| E217134731 | K083701 | 000 |
| E217134811 | K083701 | 000 |
| E217134901 | K083701 | 000 |
| E217134911 | K083701 | 000 |
| E217135411 | K083701 | 000 |
| E217135431 | K083701 | 000 |
| E217135451 | K083701 | 000 |
| E217135511 | K083701 | 000 |
| 00883205105288 | K083701 | 000 |