510(k) K172505
- Device
- MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
- Applicant
- MIS Implants Technologies Ltd.
- 510(k) number
- K172505
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-28
- Date received
- 2017-08-18
- 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
- Arbel Shezaf
- Address
- P.O. Box 7 Bar Lev Industrial Park Bar Lev Industrial Park IL 2015600 2015600
FDA Registration Numbers#
- 3009528826
- 3003781339
- 1424263
- 3007597023
- 3001082453
- 3011649314
- 9614404
- 3005728057
- 1000577893
- 3017833095
- 3001617766
- 3023265483
- 3007366413
- 3026365523
- 3043585140
- 3010178296
- 1718476
- 3002808227
- 3008791019
- 3013102320
- 3005663340
- 3008102042
- 3036190511
- 3005216725
- 1222802
- 3007031098
- 3031886796
- 9617542
- 3012187973
- 2086964
- 3007728094
- 3006796211
- 3011187779
- 3009848796
- 3013376795
- 3010407203
- 3007536957
- 3009217531
- 3018097239
- 8020776
- 3006405073
- 3015620565
- 3011103459
- 1036836
- 3005121682
- 3005914490
- 3003394081
- 3008261720
- 3011221537
- 3022316560
- 2085360
- 3017980266
- 3030039110
- 3033708818
- 2027971
- 8043792
- 3012465917
- 1226544
- 3008252900
- 3011587077
- 2249649
- 3005941719
- 3031529635
- 3013547803
- 3005497913
- 3013271380
- 3007518363
- 3013701115
- 3033519161
- 3005554774
- 3016733895
- 3018077122
- 3007923096
- 3017548645
- 2921595
- 3008252251
- 3032834812
- 3014129047
- 2245590
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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