Company ยท US
Pac-Dent, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2022. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2022 | K202674 | Medidenta High Speed Handpieces Pac-Dent, Inc. | EFB |
| May 25, 2022 | K202920 | OptiComp Pac-Dent, Inc. | EBF |
| Aug 26, 2021 | K202831 | The iMask Child's Face Mask Pac-Dent, Inc. | OXZ |
| Jul 28, 2021 | K210189 | Pac-Dent Denture Base Resin Pac-Dent, Inc. | EBI |
| Jul 26, 2021 | K210412 | Pac-Dent Ceramic Nanohybrid Resin Pac-Dent, Inc. | EBF |
| Jul 16, 2021 | K210186 | PacBond One Pac-Dent, Inc. | KLE |
| Feb 19, 2021 | K201182 | iMask Disposable Surgical Face Mask Pac-Dent, Inc. | FXX |
| Jul 6, 2020 | K200330 | RC-Prime Root Canal Preparation Cream Pac-Dent, Inc. | KJJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||