Home › Device types › DZE
Implant, Endosseous, Root-Form
FDA product code DZE · Class 2 · Dental
41,850
Registered devices
3,191,477
Adverse events
211
Recalls
1,547
510(k) clearances
Devices with this code
NA — SOUTHERN IMPLANTS (PTY) LTDDitron Dental — DITRON DENTAL LTDIDS Insight Dental Implant System — TITAN IMPLANT SYSTEMS, LLCNeodent — JJGC Indústria e Comércio de Materiais Dentários S/A.Magicore S — InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)Stage 1 Implant System — KEYSTONE DENTAL, INC.Blue Sky Bio, LLC — BLUE SKY BIO LLCImplantium — DENTIUM USATRI — TRI Dental Implants Int. AGDIO Biotite-H Implant System — DIO CorporationInclusive — Prismatik Dentalcraft, IncLW Fixture — Ossvis Co., Ltd.UNI HEX — INTRA-LOCK INTERNATIONAL, INC.AoN Implants — FAICO MEDICAL LLCSwissPlus® — ZimVie US Corp LLCSMARTLOCK — Stryker Leibinger GmbH & Co. KGCortical Implant — NORIS MEDICAL LTDLEONE SPA — LEONE SPAOT EQUATOR - OT BRIDGE — RHEIN 83 SRLAnyRidge Internal Fixture — Megagen Implant Co. LtdET IV NH Fixture Pre-Mounted — HIOSSEN, INC.Stern EX Acid Etched Implant NP 3.3x11.5mm, Machined Collar, Ti — STERNGOLD DENTAL LLCNobelActive® — Nobel Biocare ABNobelParallel™ S TiUltra™ — Nobel Biocare AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2021-11-30 | Straumann USA LLC | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Heli |
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