510(k) K172100
- Device
- URIS OMNI System
- Applicant
- TruAbutment Inc.
- 510(k) number
- K172100
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-04
- Date received
- 2017-07-11
- 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
- Brandon Kim
- Address
- 300 S. Harbor Blvd. #520 Anaheim CA US 92805 92805
FDA Registration Numbers#
- 3008770646
- 3017064961
- 3011587630
- 9617078
- 9611993
- 9681851
- 3012187973
- 3009217531
- 3011390931
- 3005497913
- 3002963873
- 3032163716
- 3006540014
- 3004036186
- 3014290448
- 3006948427
- 3018097239
- 8010516
- 1223843
- 3005115116
- 3011461101
- 8010099
- 3017548645
- 9614404
- 3011575197
- 3006034256
- 3030039110
- 3006001176
- 3010178296
- 3033519161
- 3021076825
- 1450662
- 3005409899
- 3009514134
- 1038806
- 3030447506
- 8043792
- 3014112268
- 3008309654
- 3008252900
- 3024858450
- 3004417597
- 3025517712
- 3011656326
- 3009528809
- 3008496301
- 8044131
- 3032439351
- 9617542
- 3027665899
- 2086964
- 3003402534
- 3006948193
- 3008812251
- 3012121192
- 3026365523
- 3014329459
- 9680605
- 3024185724
- 3009756327
- 3017125693
- 2029275
- 3003847101
- 3003394627
- 3001295407
- 3005728057
- 3002807112
- 3030089802
- 3032834812
- 1032347
- 1000577893
- 3001617766
- 3016733895
- 3004578807
- 1226544
- 1000244346
- 3013034344
- 3010876315
- 3007518363
Source Documents#
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261295 | MultiNeO Dental Implant System | Alpha Bio Tec , Ltd. | 2026-10-22 |
| 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 |
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