The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Kingscross Pl-c+b-10, Kingscross Pl-c+b-12, Kingscross Pl-c+b-08, Kingscross B.
| Device ID | K122039 |
| 510k Number | K122039 |
| Device Name: | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg, DE 35713 |
| Contact | Juergen Berger |
| Correspondent | Juergen Berger KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg, DE 35713 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-11 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107909 | K122039 | 000 |
| E21713788US1 | K122039 | 000 |
| E217137851 | K122039 | 000 |
| E21713784US1 | K122039 | 000 |
| E217137831 | K122039 | 000 |
| E21713782US1 | K122039 | 000 |
| E217137821 | K122039 | 000 |
| E21713781US1 | K122039 | 000 |
| E217137811 | K122039 | 000 |
| E21713780US1 | K122039 | 000 |
| E217137801 | K122039 | 000 |
| 00883205032058 | K122039 | 000 |
| 00883205032027 | K122039 | 000 |
| 00883205032010 | K122039 | 000 |
| 00883205032003 | K122039 | 000 |
| 00883205031990 | K122039 | 000 |
| E21713790US1 | K122039 | 000 |
| E217137941 | K122039 | 000 |
| E217137951 | K122039 | 000 |
| 00883205107893 | K122039 | 000 |
| 00883205107886 | K122039 | 000 |
| 00883205107879 | K122039 | 000 |
| 00883205107862 | K122039 | 000 |
| 00883205107855 | K122039 | 000 |
| 66714700000159 | K122039 | 000 |
| D813SPD13090 | K122039 | 000 |
| D813SPD13080 | K122039 | 000 |
| D813SPD13070 | K122039 | 000 |
| D813SPD13060 | K122039 | 000 |
| D813SPD13050 | K122039 | 000 |
| D813CR12200 | K122039 | 000 |
| D813CR12190 | K122039 | 000 |
| D813CR12180 | K122039 | 000 |
| E217137981 | K122039 | 000 |
| 00883205031983 | K122039 | 000 |