The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Bone Screws; Dental Bone Screws, Continuing; Screw System Tx; Screw System Tx Professional.
| Device ID | K132212 |
| 510k Number | K132212 |
| Device Name: | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss, DE D-41468 |
| Contact | Wiebke Stolten |
| Correspondent | Wiebke Stolten HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss, DE D-41468 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-16 |
| Decision Date | 2014-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E0HM79BTXPR1 | K132212 | 000 |
| E0HM36TCT090101 | K132212 | 000 |
| E0HM36TCT090131 | K132212 | 000 |
| E0HM36TCT090161 | K132212 | 000 |
| E0HM36TCT100071 | K132212 | 000 |
| E0HM36TCT100101 | K132212 | 000 |
| E0HM36TCT100131 | K132212 | 000 |
| E0HM36TCT100161 | K132212 | 000 |
| E0HM79BTX001 | K132212 | 000 |
| E0HM36TCT090071 | K132212 | 000 |