510(k) K222367
- Device
- SAVE GBR
- Applicant
- Dentis Co., Ltd.
- 510(k) number
- K222367
- Product code
- DZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-23
- Date received
- 2022-08-05
- Regulation
- 872.4880
- Classification name
- Screw, Fixation, Intraosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Gyu Ri Kim
- Address
- 99, Seongseoseo-Ro Dalseo-Gu Daegu KR 42718 42718
FDA Registration Numbers
- 3013111980
- 3004431266
- 1226425
- 1825034
- 3008868758
- 8043554
- 3007923096
- 8010177
- 3011764595
- 9613348
- 3003139373
- 9610905
- 1057946
- 8010516
- 1000606483
- 3015440604
- 2431866
- 3011530718
- 1650372
- 1060818
- 3015399803
- 3011302692
- 3017980266
- 3001239363
- 3004730368
- 3004464325
- 3022378059
- 1054986
- 9614404
- 3007031098
- 3009158523
- 8044131
- 3015212339
- 1649518
- 1066741
- 3008812251
- 3006540014
- 3015869493
- 2027148
- 3011196443
- 8010099
- 3003394081
- 9611367
- 3008261720
- 3007515069
- 3017399129
- 3034676720
- 3006017180
- 3007738812
- 1651260
- 3009201148
- 3003108161
- 3010596333
- 3009417901
- 3013527433
- 3009551666
- 3015877656
- 3000270450
- 3019807891
- 2027754
- 1721676
- 3003898943
- 1032347
- 3014937101
- 2029275
- 1828288
- 3008791302
- 3031886796
- 3008812560
- 3004049923
- 3014315560
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08806169157249 | GBR Screw | DENTIS CO. ,LTD | 2023-03-31 |
| 08806169157232 | GBR Screw | DENTIS CO. ,LTD | 2023-03-31 |
| 08800053012171 | Bonck Tack | DENTIS CO. ,LTD | 2023-03-31 |
| 08800053012164 | Bonck Tack | DENTIS CO. ,LTD | 2023-03-31 |
| 08806169157225 | GBR Screw | DENTIS CO. ,LTD | 2023-03-28 |
Other 510(k) Records For Product Code DZL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | 2025-09-29 |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025-08-13 |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025-06-27 |
| K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | 2025-01-03 |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | 2024-10-17 |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2024-09-17 |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | 2023-08-24 |
| K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | 2021-10-08 |
| K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | 2020-10-05 |
| K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019-08-09 |
| K181854 | OssBuilder System | Osstem Implant Co., Ltd. | 2019-05-07 |
| K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | 2017-10-26 |
| K161857 | Salvin Tenting Screw System | Salvin Dental Specialties | 2017-04-28 |
| K160991 | Neo GBR System | Neobiotech Co., Ltd. | 2017-01-10 |
| K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies | 2016-05-26 |