510(k) K221488
- Device
- Z7 Zirconia Implant System
- Applicant
- Z7, LLC
- 510(k) number
- K221488
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-26
- Date received
- 2022-05-23
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Root-Form
- 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
- Gerald Andrew Kaminsky
- Address
- 28 Felmley Rd. Whitehouse Station NJ US 08889 08889
FDA Registration Numbers
- 3008388248
- 9617078
- 3016784205
- 3007515069
- 3005115116
- 3009611645
- 3015978392
- 3003847101
- 3009161350
- 3043585140
- 9611993
- 3017064961
- 3010251542
- 3035820532
- 3012187973
- 3009196578
- 3042227762
- 3009514134
- 2245304
- 3011936113
- 3002807050
- 3017833095
- 3017980266
- 3009756327
- 1032347
- 1220477
- 3009528809
- 3010160527
- 3007366413
- 3016733895
- 1060818
- 3015218457
- 3008494722
- 3024185724
- 3007842672
- 1036836
- 3004201263
- 2085360
- 3007728094
- 3004730368
- 8043971
- 3010596333
- 9680605
- 3005031178
- 1054986
- 3010948854
- 3011545243
- 3002807310
- 3008309654
- 1054811
- 2031884
- 3009217531
- 1030489
- 1424263
- 3008102042
- 9617542
- 3009632672
- 2245590
- 3008793310
- 3006411780
- 3014329459
- 8010099
- 3025517712
- 3007518363
- 1222802
- 2032098
- 2921595
- 3005554774
- 3008261720
- 3013271380
- 3014270103
- 3030447506
- 3008812251
- 3006948193
- 3008910197
- 3001110146
- 3013167159
- 3017125693
- 1038806
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860010390030 | ZiNova | Z7, LLC | 2025-02-10 |
| 00860010390023 | ZiNova | Z7, LLC | 2025-02-10 |
| 00860010390016 | ZiNova | Z7, LLC | 2025-02-10 |
| 00860010390009 | ZiNova | Z7, LLC | 2025-02-10 |
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| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026-03-04 |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026-02-18 |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026-01-08 |
| K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | 2025-11-07 |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025-10-30 |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | 2025-10-10 |