Cleared Traditional

SYNTHETIC GLASS BONE GRAFT MATERIAL

K000633 · Blue Sky Bio · Dental

May 2000

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K000633 is an FDA 510(k) clearance for the SYNTHETIC GLASS BONE GRAFT MATERIAL, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Blue Sky Bio (Irvine, US). The FDA issued a Cleared decision on May 25, 2000, 90 days after receiving the submission on February 25, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K000633 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2000
Decision Date	May 25, 2000
Days to Decision	90 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.