Cleared Traditional

OsOpia Synthetic Bone Void Filler

K201546 · Revisios BV · Dental

Oct 2020

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K201546 is an FDA 510(k) clearance for the OsOpia Synthetic Bone Void Filler, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Revisios BV (3723 Mb Bilthoven, NL). The FDA issued a Cleared decision on October 2, 2020, 115 days after receiving the submission on June 9, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K201546 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2020
Decision Date	October 02, 2020
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	LYC — Bone Grafting Material, Synthetic
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.