Home › Device types › DZE
Implant, Endosseous, Root-Form
FDA product code DZE · Class 2 · Dental
42,749
Registered devices
3,262,174
Adverse events
212
Recalls
1,549
510(k) clearances
Devices with this code
IU Ball Attachment Abutment — WARANTEC.Co.,LtdGEN5™ Implant — Paragon Implant Mfg., LLCITL Dental — EMERY ENTERPRISES INCOne Piece O-Ball Dental Implant — OCO BIOMEDICAL INCSPHERO BLOCK NORMO — RHEIN 83 SRLRMO — Rmo, Inc.iSy® Implants-Set — ALTATEC GmbHDiamodent — DIAMODENT INCSmall Diameter Dental Implant — OCO BIOMEDICAL INCBrånemark System® — Nobel Biocare ABKISSES Internal Fixture — Achimhai Medical CorporationOSSTEM Implant System — Osstem Implant Co., Ltd.DIMPLO Fixture — DIMPLO Ltd.Magicore — InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)OSSTEM Implant System — Osstem Implant Co., Ltd.Aeton Medical — Aetonmedical LLCET III NH Ultra-Wide Fixture No-Mount — HIOSSEN, INC.CAMLOG® SCREW-LINE Implant, Promote® plus — ALTATEC GmbHNC Cementable Abutment — BIO CONCEPT Co., Ltd.Straumann Bone Level Tapered Implant — Institut Straumann AGLEONE SPA — LEONE SPAMagic Abutcoping (Transfer type) — InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)UF(II) Implant System — DIO CorporationTS BA Fixture System — Osstem Implant Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-12 | Straumann USA LLC | There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. |
| 2026-07-16 | Straumann USA LLC | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the la |
| 2025-07-30 | S.I.N. Implant System Ltda | Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be pac |
| 2025-05-01 | Straumann USA LLC | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| 2025-05-01 | Straumann USA LLC | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| 2025-01-10 | Nobel Biocare | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the steril |
| 2024-09-01 | SIN SISTEMA DE IMPLANTE NACIONAL S.A | Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drill |
| 2023-04-06 | Hiossen Inc. | Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm |
| 2022-07-25 | Nobel Biocare | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. |
| 2021-12-17 | Nobel Biocare Usa Llc | Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used durin |
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