DZEFDA Class 2 · 21 CFR 872.3640 · implantable
Implant, Endosseous, Root-Form
Device family · Dental
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
1,551
Manufacturers
105
Flagged signals
20
Adverse-event reports
3,527,072
Code matrix
| FDA product code | DZE |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2013 | 3 | 665.0 | 1,382 |
| Other | 2012 | 6 | 41.1 | 197 |
| Other | 2011 | 5 | 34.3 | 130 |
| Other | 2010 | 3 | 20.6 | 38 |
| Other | 2024 | 3 | 19.2 | 35 |
| Other | 2025 | 3 | 7.9 | 12 |
| Injury | 2020 | 4 | 2.6 | 4 |
| Injury | 2019 | 252 | 2.6 | 404 |
| Injury | 2023 | 5 | 2.6 | 6 |
| Injury | 2014 | 4 | 2.6 | 4 |
| Injury | 2023 | 28 | 2.6 | 43 |
| Injury | 2018 | 24 | 2.6 | 36 |
| Injury | 2023 | 4 | 2.6 | 4 |
| Injury | 2024 | 111 | 2.4 | 141 |
| Injury | 2022 | 7 | 2.3 | 6 |
| Injury | 2023 | 18 | 2.2 | 18 |
| Injury | 2025 | 244 | 2.2 | 266 |
| Injury | 2010 | 11 | 2.2 | 10 |
| Injury | 2019 | 40 | 2.1 | 37 |
| Injury | 2019 | 20 | 2.0 | 15 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 3,527,072 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Nobelpharma USA, Inc. | 51 | 1996 | — |
| Steri-Oss, Inc. | 40 | 1998 | — |
| Implant Innovations, Inc. | 37 | 2007 | — |
| Nobel Biocare AB | 30 | 2026 | — |
| Institut Straumann AG | 30 | 2026 | — |
| OSSTEM IMPLANT Co., Ltd. | 27 | 2023 | — |
| BioHorizons Implant Systems, Inc. | 26 | 2024 | — |
| Lifecore Biomedical, Inc. | 23 | 2007 | — |
| Straumann USA | 19 | 2016 | — |
| Zimmer Dental, Inc. | 19 | 2017 | — |
| DENTIS CO., LTD. | 19 | 2026 | — |
| MegaGen Implant Co., Ltd. | 16 | 2024 | — |
| HIOSSEN, INC. | 15 | 2024 | — |
| Interpore Intl. | 12 | 1996 | — |
| KJ MEDITECH Co., Ltd. | 10 | 2022 | — |
| Cowellmedi Co., Ltd. | 9 | 2024 | — |
| Dentium Co., Ltd. | 9 | 2022 | — |
| ACE SURGICAL SUPPLY CO., INC. | 9 | 2010 | — |
| Thommen Medical AG | 9 | 2017 | — |
| Blue Sky Bio, LLC | 8 | 2022 | — |
| Z-Systems AG | 8 | 2020 | — |
| curasan AG | 8 | 2001 | — |
| ARUM DENTISTRY Co., Ltd. | 7 | 2025 | — |
| DIO Corporation | 7 | 2018 | — |
| Implant Direct Sybron Manufacturing, LLC | 6 | 2023 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Adin Long Dental Implant System · Adin Dental Implant Systems , Ltd.510(k) · 2026-03-23
ZENEX Implant System_Short (R-System) · Izenimplant Co., Ltd.510(k) · 2026-03-16
Straumann® BLC Implants - Indication Widening · Institut Straumann AG510(k) · 2026-03-10
Dentis SQ-SL AXEL Fixture · Dentis Co., Ltd.510(k) · 2026-03-04
Nobel Biocare S Series Implants · Nobel Biocare AB510(k) · 2026-02-18
BIORES Dental Implant System · Chengdu Besmile Medical Technology Co., Ltd.510(k) · 2026-02-02
ZENEX Implant System_R-System · Izenimplant Co., Ltd.510(k) · 2026-01-08
GEN5 and GEN5+ 3.3mmD Dental Implants · Paragon Implant Mfg., LLC510(k) · 2025-12-23
NizPlant Dental Implant System · Paragon Implant Mfg., LLC510(k) · 2025-12-23
DIMPLO Implant System · DIMPLO, Ltd.510(k) · 2025-12-22
Pterygoid Indication for GM Helix Implants · JJGC Indústria e Comércio de Materiais Dentários S.A.510(k) · 2025-12-12
S.I.N. Tapered Pro Conical Zygoma Implant System · S.I.N. Implant System Ltda510(k) · 2025-11-07
GEN5 and GEN5+ Dental Implant System · Paragon Implant Mfg., LLC510(k) · 2025-10-30
HexaPLUS S OneDrill Implant System · Osseofuse International, Inc.510(k) · 2025-10-10
Paltop Dental Implant System · Paltop Advanced Dental Solutions, Ltd.510(k) · 2025-09-29
S.I.N. Dental Implant System · S.I.N. Implant System Ltda510(k) · 2025-09-26
JDEvolution Plus L and JDEvolution Plus LE · Jdentalcare Srl510(k) · 2025-09-25
NobelZygoma TiUltra Implant system · Nobel Biocare AB510(k) · 2025-08-25
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System · Dentsply Sirona, Inc.510(k) · 2025-08-21
Neodent Implant System - Zirconia Implant System · JJGC Indústria e Comércio de Materiais Dentários S.A.510(k) · 2025-08-18
S.I.N. Dental Implant System · S.I.N. Implant System Ltda510(k) · 2025-08-13
Straumann® RidgeFit Implants · Institut Straumann AG510(k) · 2025-08-12
MIS LYNX Conical Connection Implant System · Dentsply Sirona, Inc.510(k) · 2025-07-24
DESS® Dental Implants · Terrats Medical SL510(k) · 2025-07-23
SD TL Implant System · Arum Dentistry Co., Ltd.510(k) · 2025-07-23
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.