Product code KXR
- Device name
- Applicator, Resin
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3140
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- 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 |
|---|---|---|---|
| 07615208482430 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-03-13 |
| 07615208482447 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-03-13 |
| 07615208482751 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-03-13 |
| 07615208294828 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-01-15 |
| 07615208294835 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-01-15 |
| 07615208296747 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-01-15 |
| 07615208296754 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-01-15 |
| 07615208294804 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2026-01-15 |
| 07615208294842 | OptraSculpt | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-08-07 |
| 10810111542699 | Accessory | BISCO INC. | 2023-01-17 |
| 10810111542705 | Accessory | BISCO INC. | 2022-11-21 |
| 10810111542682 | Accessory | BISCO INC. | 2022-11-21 |
| 10810111542668 | Accessory | BISCO INC. | 2022-11-03 |
| 10810111542675 | Accessory | BISCO INC. | 2022-10-11 |
| 10304040156046 | Henry Schein | HENRY SCHEIN, INC. | 2022-03-31 |
| 10304040156039 | Henry Schein | HENRY SCHEIN, INC. | 2022-03-31 |
| 10810063750036 | Safco Micro Applicators | SAFCO DENTAL SUPPLY CO. | 2022-03-30 |
| 10810063750050 | Safco Micro Applicators | SAFCO DENTAL SUPPLY CO. | 2022-03-30 |
| 10810063750067 | Safco Micro Applicators | SAFCO DENTAL SUPPLY CO. | 2022-03-30 |
| 10810063750043 | Safco Micro Applicators | SAFCO DENTAL SUPPLY CO. | 2021-11-30 |
| 10304040055981 | Henry Schein | HENRY SCHEIN, INC. | 2021-05-07 |
| 10304040051419 | Henry Schein | HENRY SCHEIN, INC. | 2020-12-28 |
| 10190886010730 | OCS ETCH GEL SYRINGE | G & H Wire Company, Inc. | 2017-01-06 |
| 10190886000724 | TIP-REPLACEMENT GEL 22 GA 50PK | G & H Wire Company, Inc. | 2016-10-03 |
| 10190886000526 | ETCHANT SYRINGE TIPS FOR BSET15 | G & H Wire Company, Inc. | 2016-10-03 |
| 10814978020260 | Disposable Applicators | Kerr Corporation | 2016-08-01 |
| 10841396107310 | Disposable Applicators | Kerr Corporation | 2016-08-01 |
| 10841396107327 | Applicator Tips | Kerr Corporation | 2016-08-01 |
| 10841396107334 | Guardian Seal | Kerr Corporation | 2016-08-01 |
| 10841396107341 | Flowable Brush Refill | Kerr Corporation | 2016-08-01 |