Brea, CA, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 2 | 2022-05-25 |
| EFB | Handpiece, Air-Powered, Dental | Class I | Dental | 1 | 2022-12-12 |
| OXZ | Pediatric/Child Facemask | Class II | General, Plastic Surgery | 1 | 2021-08-26 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Class II | Dental | 1 | 2021-07-28 |
| KLE | Agent, Tooth Bonding, Resin | Class II | Dental | 1 | 2021-07-16 |
| FXX | Mask, Surgical | Class II | General, Plastic Surgery | 1 | 2021-02-19 |
| KJJ | Cleanser, Root Canal | Unclassified | Unknown | 1 | 2020-07-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2022-12-12 | K202674 | Medidenta High Speed Handpieces | EFB | Class I | Dental |
| 2022-05-25 | K202920 | OptiComp | EBF | Class II | Dental |
| 2021-08-26 | K202831 | The iMask Child's Face Mask | OXZ | Class II | General, Plastic Surgery |
| 2021-07-28 | K210189 | Pac-Dent Denture Base Resin | EBI | Class II | Dental |
| 2021-07-26 | K210412 | Pac-Dent Ceramic Nanohybrid Resin | EBF | Class II | Dental |
| 2021-07-16 | K210186 | PacBond One | KLE | Class II | Dental |
| 2021-02-19 | K201182 | iMask Disposable Surgical Face Mask | FXX | Class II | General, Plastic Surgery |
| 2020-07-06 | K200330 | RC-Prime Root Canal Preparation Cream | KJJ | Unclassified | Unknown |