Straumann Bone Level Tapered Implants
K-Number: K153758 · 2016-03-23
ApplicantInstitut Straumann AG
Decision Date2016-03-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann Bone Level Tapered Implants is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2016-03-23 under approval number K153758. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Straumann Bone Level Tapered Implants?
Straumann Bone Level Tapered Implants is a medical device that received FDA 510(k) clearance on 2016-03-23. It is manufactured by Institut Straumann AG. The 510(k) number is K153758.
When was Straumann Bone Level Tapered Implants approved by the FDA?
Straumann Bone Level Tapered Implants received FDA 510(k) clearance on 2016-03-23, under approval number K153758.
What company makes Straumann Bone Level Tapered Implants?
Straumann Bone Level Tapered Implants is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann Bone Level Tapered Implants?
The FDA product code for Straumann Bone Level Tapered Implants is DZE.
Related Clinical Trials
NCT07608523
Marginal Bone Level Around Dental Implants in Periodontitis Patients
COMPLETED
NCT07240493
BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement
COMPLETED
NCT04251377
Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection
ACTIVE_NOT_RECRUITING
NCT06012071
Two-piece Zirconia Implants With Two Various Platforms
RECRUITING
NCT02569671
Bone Level Tapered Multi-Center Study
COMPLETED
NCT03908177
Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.
COMPLETED
Related PubMed Literature
PMID: 41453025
Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023.
The Journal of the American Academy of Orthopaedic Surgeons (2025)
PMID: 40528079
The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey.
Therapeutic innovation & regulatory science (2025)
Other Devices by Institut Straumann AG
Related Devices (Code: DZE)
K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG
K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd.
K163043Zeramex P6 Dental Implant SystemDentalpoint AG
K161497Dental Implants and AbutmentsDitron Precision, Ltd.
K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.
K151970KJ Mini Implant SystemKj Meditech Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.