Cleared Traditional

S1

K231672 · Medpark Co., Ltd. · Dental

Oct 2023

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K231672 is an FDA 510(k) clearance for the S1, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Medpark Co., Ltd. (Buk-Gu, KR). The FDA issued a Cleared decision on October 13, 2023, 127 days after receiving the submission on June 8, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K231672 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2023
Decision Date	October 13, 2023
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPM — Bone Grafting Material, Animal Source
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.