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 |
E217137951 | K122039 | 000 |
E217137941 | K122039 | 000 |
E21713790US1 | 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 |
E217137981 | K122039 | 000 |
D813CR12180 | K122039 | 000 |
D813CR12190 | 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 |
E217137801 | K122039 | 000 |