510(k) K151916
- Device
- TRI Dental Implant System
- Applicant
- TRI DENTAL IMPLANTS INT. AG
- 510(k) number
- K151916
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-18
- Date received
- 2015-07-13
- 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
- SANDRO VENANZONI
- Address
- Lindenstrasse 14 Baar CH CH-6340 CH-6340
FDA Registration Numbers#
- 3011936113
- 3001082453
- 2023623
- 2245590
- 3004201263
- 3013111692
- 2029275
- 3006405073
- 2032098
- 3007518363
- 3006592743
- 3025517712
- 3015775866
- 3004049923
- 8020776
- 9613283
- 9611993
- 3011587077
- 3015160953
- 1424785
- 3031462380
- 3038549074
- 2024024
- 3008088588
- 3014596751
- 3011656326
- 9680605
- 2031884
- 8030870
- 8010591
- 9611992
- 2921595
- 3005216725
- 3024859204
- 3008252900
- 3009528826
- 3011103459
- 3009611645
- 3011187779
- 2183744
- 2530808
- 8043971
- 3008102042
- 3010251542
- 1423662
- 8044131
- 3013167159
- 3009727738
- 3009761487
- 3004431266
- 3009840806
- 3006540014
- 3001295407
- 3012422333
- 3030447506
- 1036836
- 2245304
- 9617542
- 3001617766
- 3010178296
- 3026365523
- 3003394081
- 3021076825
- 3005121682
- 3007126709
- 3042971970
- 3008261720
- 3033708818
- 3007536957
- 3042227762
- 3010730876
- 3002807050
- 3018662547
- 3004036186
- 3014112268
- 3009528809
- 3017980266
- 3033519161
- 3005115116
- 3005290844
Source Documents#
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | 2026-09-17 |
| 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 |
Legacy Summary#
summary
FDA Review#
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