Product code DZE
- Device name
- Implant, Endosseous, Root-Form
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3640
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P800035S010 | PERI-OSS | Curasan AG | 2001-10-04 |
| P860012 | ALVEOFORM TM BIOGRAFT | Collagen Corp. | 1988-10-28 |
| P800035S007 | SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) | Curasan AG | 1984-08-07 |
| P800035S008 | AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG | Curasan AG | 1983-11-10 |
| P800035S004 | SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) | Curasan AG | 1983-06-07 |
| P800035S003 | SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) | Curasan AG | 1982-11-08 |
| P800035S005 | SYNTHOGRAFT(TM) LARGE GRANULAR (LG) | Curasan AG | 1982-08-09 |
| P800035S002 | SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) | Curasan AG | 1982-07-16 |
| P800035S001 | SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) | Curasan AG | 1982-03-12 |
Related 510(k) Records#
| 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 |
| 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 |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-09-26 |
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | 2025-09-25 |
| K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | 2025-08-25 |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | Dentsply Sirona, Inc. | 2025-08-21 |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-08-18 |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-08-13 |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | 2025-08-12 |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2025-07-24 |
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-07-23 |
| K251280 | DESS® Dental Implants | Terrats Medical SL | 2025-07-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810126046871 | ET III Fixture SA Regular No Mount | HIOSSEN, INC. | 2026-07-14 |
| 08806388246601 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246786 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246779 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246755 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246748 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246731 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246724 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246717 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246700 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246687 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246670 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246663 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246656 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246649 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246632 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246694 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246625 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246618 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-07-01 |
| 08806388246908 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246892 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246885 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246878 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246861 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246854 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246847 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246762 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-30 |
| 08806388246830 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-29 |
| 08806388246823 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-29 |
| 08806388246816 | AnyOne Onestage Fixture | Megagen Implant Co. Ltd | 2021-06-29 |