510(k) K231235
- Device
- LW UCLA Abutment
- Applicant
- Ossvis Co., Ltd.
- 510(k) number
- K231235
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-15
- Date received
- 2023-04-28
- Regulation
- 872.3630
- Classification name
- Abutment, Implant, Dental, Endosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Young Jae Kim
- Address
- 7f And B1, 38, Burim-Ro 170beon-Gil, Dongan-Gu Anyang-Si KR 14055 14055
FDA Registration Numbers
- 3008388248
- 3039397999
- 3007515069
- 3005115116
- 3009611645
- 3015978392
- 3003847101
- 3009161350
- 3043585140
- 9611993
- 3013465593
- 3017064961
- 3010287737
- 3013527433
- 3010251542
- 3012187973
- 3007740664
- 3009196578
- 3015194291
- 3042227762
- 3009514134
- 2436986
- 3011936113
- 3002807050
- 3017980266
- 3017833095
- 3009756327
- 3013111980
- 1220477
- 3009528809
- 3010160527
- 3019793783
- 3016733895
- 1060818
- 3007366413
- 3015218457
- 3009646999
- 3008494722
- 3024185724
- 3007842672
- 3013578168
- 3032802037
- 1036836
- 3004201263
- 3007728094
- 3004730368
- 1222315
- 8043971
- 3038715999
- 3010596333
- 9680605
- 3005031178
- 1054986
- 3010948854
- 3011545243
- 3002807310
- 3008309654
- 3009217531
- 1424263
- 3008102042
- 9617542
- 3009632672
- 2245590
- 3008793310
- 3006411780
- 3014329459
- 3007518363
- 1222802
- 2032098
- 2921595
- 3005554774
- 3008261720
- 1531062
- 3013271380
- 3014270103
- 3009432160
- 3035532393
- 3008812251
- 3006948193
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809918250154 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250147 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250130 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250123 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250116 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250109 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250093 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250086 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250079 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250062 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250055 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250048 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250031 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250024 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250017 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
| 08809918250000 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-12-21 |
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| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025-12-18 |