The following data is part of a premarket notification filed by Pac-dent International, Inc. with the FDA for Pac-dent Barrier Sleeve, Cover-it(tm) Barrier Film.
| Device ID | K151123 |
| 510k Number | K151123 |
| Device Name: | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film |
| Classification | Dental Barriers And Sleeves |
| Applicant | Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Contact | Wenying Zhu |
| Correspondent | Wenying Zhu Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-28 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D702RT3004150 | K151123 | 000 |
| 20302730002342 | K151123 | 000 |
| 20302730002359 | K151123 | 000 |
| 20302730002366 | K151123 | 000 |
| 20302730002373 | K151123 | 000 |
| 10302730002383 | K151123 | 000 |
| 10302730002390 | K151123 | 000 |
| 00723896018149 | K151123 | 000 |
| 00723896018170 | K151123 | 000 |
| 10302736700504 | K151123 | 000 |
| 20302736701508 | K151123 | 000 |
| 20302736702505 | K151123 | 000 |
| 20302736703502 | K151123 | 000 |
| 20302736704509 | K151123 | 000 |
| 00815967025924 | K151123 | 000 |