Cleared Traditional

Straumann BoneCeramic

K201051 · Institut Straumann AG · Dental

Sep 2020

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K201051 is an FDA 510(k) clearance for the Straumann BoneCeramic, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on September 24, 2020, 156 days after receiving the submission on April 21, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K201051 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2020
Decision Date	September 24, 2020
Days to Decision	156 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.