510(k) K760008
- Device
- DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL
- Applicant
- KYOCERA INTERNATIONAL, INC.
- 510(k) number
- K760008
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-05
- Date received
- 1976-06-08
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Root-form
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Other 510(k) Records For Product Code DZE
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|---|---|---|---|
| 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 |
| 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 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 |
| 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 |
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