510(k) K170608
- Device
- UF(II) Implant System
- Applicant
- DIO Corporation
- 510(k) number
- K170608
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-30
- Date received
- 2017-03-01
- 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
- Jiae Park
- Address
- 66 Centumseo-Ro Busan KR 48058 48058
FDA Registration Numbers#
- 3000203391
- 3014290448
- 3031553803
- 3024859204
- 3008812251
- 3024852742
- 9611992
- 8010099
- 3008870565
- 3004638532
- 3031886796
- 3001295407
- 3013034344
- 3007536957
- 3012121192
- 1423662
- 3011656326
- 1036836
- 3005643710
- 3008959419
- 3009737865
- 3022316560
- 9613866
- 3003236702
- 3008791302
- 1718476
- 3001110146
- 3003184527
- 3009201148
- 3015527825
- 8010177
- 9614404
- 3017548645
- 3013102320
- 3017064961
- 1221541
- 3013173272
- 3014938434
- 8010516
- 3018094310
- 3015160953
- 9681851
- 9680963
- 3007518363
- 2027062
- 3010178296
- 3010363503
- 2023950
- 3017833095
- 8044131
- 3005503242
- 3021076825
- 3009196578
- 3033519161
- 3010948854
- 1824199
- 3025338240
- 3031493119
- 3011824442
- 2523430
- 1030489
- 3007597023
- 2086964
- 3011891801
- 9613348
- 3002963873
- 1424785
- 1226544
- 3003402534
- 3016447764
- 3009840806
- 3002808227
- 3015775866
- 1223843
- 3005497913
- 3007283751
- 1060818
- 3004201263
- 3024858450
- 1410097
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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