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 |
|---|---|---|---|
| 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 |
| 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 |
| K251280 | DESS® Dental Implants | Terrats Medical SL | 2025-07-23 |
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-07-23 |
| K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025-07-09 |
| K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | 2025-07-03 |
| K251660 | T3 Pro Implants– ZimVie Packaging System | Biomet 3i, LLC | 2025-06-27 |
| K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | 2025-06-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800070229132 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229330 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229323 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229316 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229309 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229293 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229286 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229279 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229262 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229255 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229248 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229224 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229125 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229149 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229156 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229163 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229170 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229187 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229194 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229200 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229217 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08800070229231 | ZENEX MULTI Fixture | Izenimplant Co., Ltd. | 2026-06-09 |
| 08806388221080 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-29 |
| 08806388221066 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-25 |
| 08806388221073 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-25 |
| 08806388221097 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-25 |
| 08806388221103 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-25 |
| 08806388221110 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-25 |
| 08806388221127 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-25 |
| 08806388221134 | AnyOne Internal Fixture | Megagen Implant Co. Ltd | 2015-06-25 |