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FDA 510(k)

InRoad® Dental Synthetic Bone Graft

K-Number: K202675 · 2022-03-04

ApplicantOsteogene Tech Corp
Decision Date2022-03-04
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

InRoad® Dental Synthetic Bone Graft is a medical device manufactured by Osteogene Tech Corp. It received FDA 510(k) clearance on 2022-03-04 under approval number K202675. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InRoad® Dental Synthetic Bone Graft?

InRoad® Dental Synthetic Bone Graft is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Osteogene Tech Corp. The 510(k) number is K202675.

When was InRoad® Dental Synthetic Bone Graft approved by the FDA?

InRoad® Dental Synthetic Bone Graft received FDA 510(k) clearance on 2022-03-04, under approval number K202675.

What company makes InRoad® Dental Synthetic Bone Graft?

InRoad® Dental Synthetic Bone Graft is manufactured by Osteogene Tech Corp.

What is the FDA product code for InRoad® Dental Synthetic Bone Graft?

The FDA product code for InRoad® Dental Synthetic Bone Graft is LYC.

Related Clinical Trials

NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING NCT07569146 Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone. COMPLETED NCT06533397 The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation RECRUITING NCT07225751 A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions. RECRUITING NCT07512011 Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure NOT_YET_RECRUITING NCT07492576 Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management RECRUITING

Related Devices (Code: LYC)

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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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