510(k) K251605
- Device
- DIMPLO Implant System
- Applicant
- DIMPLO, Ltd.
- 510(k) number
- K251605
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-22
- Date received
- 2025-05-27
- 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
- N
Related Records
Applicant Contact
- Contact
- Jiyeon Sung
- Address
- 2f, 16, Hwangsaeal-Ro, Yeonje-Gu Busan KR 47507 47507
FDA Registration Numbers
- 1450662
- 9612300
- 3036190511
- 2027062
- 2183744
- 3012172055
- 3023852420
- 3016447764
- 3008770646
- 3005290844
- 3007842672
- 3012422333
- 3014118611
- 3002807112
- 3030447506
- 3013111692
- 1038806
- 3030690317
- 2918719
- 3007728094
- 3010303805
- 2086964
- 3024858450
- 3009528809
- 3009756327
- 8010177
- 3016784205
- 3011221537
- 3024852742
- 3009761487
- 3009847764
- 3004417597
- 1000244346
- 3001082453
- 3009632672
- 3013547803
- 3005663340
- 8010591
- 1030489
- 1222802
- 3033708818
- 3042272797
- 3009528826
- 3008870565
- 3013102320
- 3006592743
- 3006001176
- 3010383847
- 3014596751
- 9617078
- 1054986
- 3017833095
- 9614404
- 3008186372
- 3010287685
- 3004578807
- 3009727738
- 3008252251
- 3036779616
- 3007515069
- 3006017180
- 3023535580
- 3013701115
- 3014938434
- 1032347
- 1627417
- 3010393542
- 2029275
- 3004049923
- 3004431266
- 1221541
- 9680605
- 9613662
- 3014540272
- 3009848796
- 3010876315
- 3006411780
- 8010468
- 3022316560
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800362100088 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100170 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100163 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100156 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100149 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100132 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100125 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100118 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100101 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100095 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100187 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100071 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100064 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100057 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100040 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100033 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100026 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100019 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100002 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100279 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100354 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100347 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100330 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100323 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100316 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100309 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100293 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100286 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100361 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
| 08800362100262 | DIMPLO Fixture | DIMPLO Ltd. | 2026-03-20 |
Other 510(k) Records For Product Code DZE
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|---|---|---|---|
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| 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 |
| K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | 2025-11-07 |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025-10-30 |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | 2025-10-10 |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 |