The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for Resin For Temporary Crown & Bridge.
| Device ID | K180657 |
| 510k Number | K180657 |
| Device Name: | Resin For Temporary Crown & Bridge |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Dentis Co., Ltd. 6, Yuram-ro, Dong-gu Daegu, KR 41065 |
| Contact | Dong-hun Jang |
| Correspondent | Soojung Moon Allura Medical Solution Inc. 8141 Lampson Ave. #4 Garden Grove, CA 92841 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-13 |
| Decision Date | 2018-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806169157126 | K180657 | 000 |