510(k) K052951
- Device
- ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
- Applicant
- INNOVA LIFE SCIENCES CORP.
- 510(k) number
- K052951
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-01-27
- Date received
- 2005-10-20
- 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
- HOWARD HOLSTEIN
- Address
- 555 13th St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3014596751
- 1824199
- 3013111692
- 3016447764
- 3001617766
- 3015775866
- 3014938434
- 3003402534
- 3009514134
- 3018097239
- 2022435
- 3017548645
- 3011587630
- 1000461041
- 3009528826
- 1643817
- 1038806
- 2027971
- 3001295407
- 3010392243
- 3009737865
- 8010591
- 8043792
- 3005290844
- 3013167159
- 3015160953
- 3012422333
- 3009756327
- 3017013344
- 2530808
- 3008252900
- 3008388248
- 3030039110
- 2183744
- 1057946
- 3021630667
- 3032834812
- 3014290448
- 3008252251
- 2086964
- 3010160527
- 3007597023
- 3007649394
- 9617542
- 3017064961
- 3006001176
- 3011103459
- 3013264549
- 3033524643
- 3008886124
- 3004201263
- 3018662547
- 3011824442
- 3007923096
- 3004711948
- 3011221537
- 2023623
- 3040978916
- 9613662
- 8030870
- 3026365523
- 9610905
- 2183828
- 3029973218
- 3003477135
- 3003184527
- 1649518
- 3025517712
- 3010303805
- 3010596333
- 3009528809
- 9612468
- 3024852742
- 3010032042
- 2085360
- 9612300
- 8043971
- 3011575197
- 9611253
- 3020144887
Source Documents#
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#
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