510(k) K070570
- Device
- DIO IMPLANT SYSTEM
- Applicant
- DIO DEPARTMENT DSI, INC.
- 510(k) number
- K070570
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-15
- Date received
- 2007-02-28
- 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
- KENNY LIM
- Address
- 13340 E Firestone Blvd. Suite J Santa Fe Springs CA US 90670 90670
FDA Registration Numbers#
- 3024852742
- 3012422333
- 3006948193
- 3036190511
- 1226544
- 1718476
- 3009217531
- 3010392243
- 3031462380
- 9613662
- 3016172557
- 3011891801
- 8031058
- 1038806
- 3001295407
- 3017840051
- 3004417597
- 3010162973
- 3027494823
- 3011545243
- 3024859204
- 3009528809
- 1000244346
- 2087481
- 3013701115
- 3007536957
- 3011461101
- 3025517712
- 3005216725
- 3012106319
- 3038136479
- 3008309654
- 1643817
- 3036779616
- 3032163716
- 8020776
- 3017125693
- 3031553803
- 3011936113
- 3003394081
- 3006411780
- 9680963
- 9613866
- 3032439351
- 1824199
- 3006110126
- 3011276344
- 9612300
- 8030870
- 3004638532
- 3005497913
- 3014290448
- 3003236702
- 3006017180
- 3003394627
- 3011808221
- 3018094310
- 3010705004
- 3007728094
- 3008494722
- 3005941719
- 3005115116
- 3007518363
- 3008770646
- 3009201148
- 2027754
- 3006540014
- 1036836
- 3038549074
- 1060818
- 3002963873
- 3011221537
- 3001617766
- 3005663340
- 3008088588
- 3021630667
- 3005121682
- 3011656326
- 2024024
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases