510(k) K200867
- Device
- Implantswiss Dental Implant System And Implantswiss Dental Abutment System
- Applicant
- Novodent SA
- 510(k) number
- K200867
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-28
- Date received
- 2020-04-01
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Root-form
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cem Kocer
- Address
- Y-Parc Technopole Ave. Des Sciences 11 Yverdons-Les-Bains CH CH1400 CH1400
FDA Registration Numbers#
- 3030039110
- 3005121682
- 3031529635
- 3006110126
- 3008791019
- 3040978916
- 3015775866
- 8010591
- 3014129047
- 8030870
- 2027062
- 3002807050
- 3004431266
- 3009514134
- 1718476
- 3012187973
- 3011390931
- 2530808
- 3038136479
- 1723412
- 2183828
- 3015383403
- 3032834812
- 3014329459
- 3025517712
- 3006948193
- 3010948854
- 3006034256
- 9680963
- 3010876315
- 3008496301
- 3008088588
- 1054986
- 3010251542
- 2024024
- 3036779616
- 3010160527
- 3010705004
- 3009840806
- 3017125693
- 3009217531
- 3007515069
- 1410097
- 8044131
- 3002808227
- 3009848796
- 3012635238
- 3006017180
- 3010287685
- 3017399129
- 8043971
- 3025338240
- 3014112268
- 3010363503
- 3024185724
- 3007923096
- 3015218457
- 8031058
- 3013167159
- 3030690317
- 1220477
- 3009756327
- 2245590
- 3007689689
- 3010303805
- 3006405073
- 3010162973
- 1450662
- 2031884
- 3011649314
- 3010730876
- 3031553803
- 2921595
- 9614404
- 3031493119
- 3005554774
- 3013173272
- 3042227762
- 3010407203
Source Documents#
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | 2026-06-25 |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | 2026-06-18 |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026-06-18 |
| K260006 | INOSS System | Inosys, Inc. | 2026-06-17 |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | 2026-05-12 |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | 2026-03-23 |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026-03-16 |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026-03-10 |
| 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 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 |
| K252145 | GEN5™ and GEN5+™ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 |
Legacy Summary#
summary
FDA Review#
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