510(k) K181266
- Device
- Implantswiss Dental Implant System, Implantswiss Dental Abutment System
- Applicant
- Novodent SA
- 510(k) number
- K181266
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-01
- Date received
- 2018-05-14
- 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
Applicant Contact#
- Contact
- Cem Kocer
- Address
- Y-Parc Technopole Ave. Des Sciences 11 Yverdons-Les-Bains CH CH1400 CH1400
FDA Registration Numbers#
- 3013271380
- 3006948193
- 3009611645
- 3002807112
- 3005121682
- 3029820793
- 1030489
- 1032347
- 8030870
- 3004638532
- 3010610960
- 3012106319
- 3013102320
- 9611993
- 3011649314
- 3014118611
- 3007366413
- 8010591
- 1000461041
- 3008102042
- 3007649394
- 3008494722
- 3002963873
- 3005503242
- 3009217531
- 2133778
- 3009756327
- 3017980266
- 3013111692
- 3008886124
- 3010392243
- 3010287729
- 3013701115
- 2921595
- 3013173272
- 3010303805
- 3003394081
- 3001295407
- 3009847764
- 3033524643
- 3008870565
- 3010393542
- 8010099
- 8031058
- 3010407203
- 3007518363
- 3016099073
- 3010948854
- 3009632672
- 2085360
- 9613348
- 3042227762
- 3007031098
- 3005663340
- 3013376795
- 3014540272
- 3002807310
- 3008496301
- 3011656326
- 8043792
- 1649518
- 3010032042
- 3011575197
- 3043585140
- 3023852420
- 3024859204
- 3012172055
- 3003847101
- 2087259
- 3031493119
- 2023623
- 3017399129
- 2087481
- 3004730368
- 9613866
- 3005554774
- 3007515069
- 1424785
- 3014329459
- 1220477
Source Documents#
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260463 | ZEROS Dental Implant System | Zeros Co., Ltd. | 2026-08-19 |
| 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 |
Legacy Summary#
summary
FDA Review#
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