The following data is part of a premarket notification filed by Ktk Medical Supplies Gmbh with the FDA for Brightglass Brightglass M.
| Device ID | K122025 |
| 510k Number | K122025 |
| Device Name: | BRIGHTGLASS BRIGHTGLASS M |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | KTK MEDICAL SUPPLIES GMBH INDUSTRIESTR. 16 Germering, DE D-821110 |
| Contact | Thomas Lottermoser |
| Correspondent | Thomas Lottermoser KTK MEDICAL SUPPLIES GMBH INDUSTRIESTR. 16 Germering, DE D-821110 |
| 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 | 2012-10-09 |
| Summary: | summary |