The following data is part of a premarket notification filed by Pac-dent International, Inc. with the FDA for Gingident Gingival Retraction Paste.
| Device ID | K162662 |
| 510k Number | K162662 |
| Device Name: | GingiDent Gingival Retraction Paste |
| Classification | Cord, Retraction |
| Applicant | PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE Brea, CA 92821 |
| Contact | Jiaqing Wu |
| Correspondent | Jiahe Li PAC-DENT INTERNATIONAL, INC. 670 Endeavor Circle Brea, CA 92821 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-10-20 |
| Summary: | summary |