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FDA 510(k)

Immediate Molar Implants

K-Number: K241753 · 2024-10-23

ApplicantBiomet 3i, LLC
Decision Date2024-10-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Immediate Molar Implants is a medical device manufactured by Biomet 3i, LLC. It received FDA 510(k) clearance on 2024-10-23 under approval number K241753. 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 Immediate Molar Implants?

Immediate Molar Implants is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Biomet 3i, LLC. The 510(k) number is K241753.

When was Immediate Molar Implants approved by the FDA?

Immediate Molar Implants received FDA 510(k) clearance on 2024-10-23, under approval number K241753.

What company makes Immediate Molar Implants?

Immediate Molar Implants is manufactured by Biomet 3i, LLC.

What is the FDA product code for Immediate Molar Implants?

The FDA product code for Immediate Molar Implants is DZE.

Related Clinical Trials

NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED NCT07574099 Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla ACTIVE_NOT_RECRUITING NCT07569146 Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone. COMPLETED NCT05081284 Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix ACTIVE_NOT_RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED

Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026)

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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.

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