Product code BRW
- Device name
- Protector, Dental
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5820
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800017902289 | EZ BITE BLOCK SOFT MOUTH PROP | DXM CO., LTD | 2025-12-18 |
| 08800017902296 | EZ BITE BLOCK SOFT MOUTH PROP | DXM CO., LTD | 2025-12-18 |
| 08800017901817 | EZ Bite block | DXM CO., LTD | 2025-12-16 |
| 00630094199702 | Bioseal Inc. | BIOSEAL | 2023-12-12 |
| 00630094199320 | Bioseal Inc. | BIOSEAL | 2023-12-11 |
| 00630094199306 | Bioseal Inc. | BIOSEAL | 2023-12-11 |
| 00630094199252 | Bioseal Inc. | BIOSEAL | 2023-12-11 |
| 00630094199207 | Bioseal Inc. | BIOSEAL | 2023-12-11 |
| 00630094199139 | Bioseal Inc. | BIOSEAL | 2023-12-07 |
| 00630094199122 | Bioseal Inc. | BIOSEAL | 2023-12-07 |
| 00630094199115 | Bioseal Inc. | BIOSEAL | 2023-12-07 |
| 00630094199016 | Bioseal Inc. | BIOSEAL | 2023-12-07 |
| 08800017901824 | EZ Bite block | DXM CO., LTD | 2023-07-26 |
| D033003610981 | Zekrya Large Arc | DMG AMERICA, LLC | 2022-12-12 |
| D033003610971 | Zekrya Small Arc | DMG AMERICA, LLC | 2022-12-12 |
| D033003610961 | Zekrya Gingival Protector Kit | DMG AMERICA, LLC | 2022-12-12 |
| B005E1260506 | AincA® | ANESTHESIA ASSOCIATES, INC. | 2021-03-31 |
| B005E1260103 | AincA® | ANESTHESIA ASSOCIATES, INC. | 2021-03-31 |
| M6334281820 | JEDMED | JEDMED INSTRUMENT COMPANY | 2020-11-05 |
| 10641043812136 | Tooth Protector | MERCURY ENTERPRISES, INC. | 2020-08-04 |
| 20697660004864 | OPSoft® Mouthguards for laser (10 units) | Oculo-Plastik Inc | 2019-11-25 |
| 10697660004874 | OPSoft® Mouthguards for laser (1 unit) | Oculo-Plastik Inc | 2019-11-25 |
| 14026704646712 | PILLING | TELEFLEX INCORPORATED | 2018-10-22 |
| 00618029810328 | Toothette Oral Care | SAGE PRODUCTS, LLC | 2016-09-24 |
| 00643169279063 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169273405 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169203150 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169195844 | NA | Medtronic CryoCath LP | 2014-09-23 |
| 00613994775955 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00613994686077 | NA | MEDTRONIC, INC. | 2014-09-23 |