510(k) K210523
- Device
- Implanova
- Applicant
- Dental Evolutions Inc.
- 510(k) number
- K210523
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-30
- Date received
- 2021-02-23
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Root-form
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Matthew Mineros
- Address
- 9100 Wilshire Blvd. Suite 448w Beverly Hills CA US 90212 90212
FDA Registration Numbers#
- 3029820793
- 3017548645
- 3029973218
- 3009528809
- 3009737865
- 3015218457
- 3015160953
- 3011649314
- 3000203391
- 3011221537
- 3043585140
- 3011587630
- 3014270103
- 3009325911
- 2530808
- 3005643710
- 3005290844
- 3004036186
- 9613866
- 3016784205
- 3006405073
- 3024185724
- 3011808221
- 3005409899
- 8010099
- 3008494722
- 1424263
- 3008102042
- 3007728094
- 3012121192
- 2245590
- 2523430
- 3008388248
- 3008959419
- 1643817
- 3038136479
- 3010303805
- 3032834812
- 2027754
- 3002808227
- 3027494823
- 2022435
- 3011587077
- 3013111692
- 3013701115
- 1220477
- 3005914490
- 2032098
- 3011656326
- 3011276344
- 3008186372
- 3008770646
- 8010468
- 3003781339
- 3007842672
- 9613283
- 3005941719
- 3024852742
- 3020144887
- 3006796211
- 3007518363
- 3038718579
- 8043971
- 3023852420
- 3007126709
- 3010032042
- 1649518
- 3010251542
- 3017399129
- 3010162973
- 3012422333
- 1054811
- 3013173272
- 2024024
- 3004417597
- 3011390931
- 9612468
- 2029005
- 3016172557
- 8044131
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 |
Legacy Summary#
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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