Cleared Traditional

SAVE GBR

K222451 · Dentis Co., Ltd. · Dental

Feb 2023

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K222451 is an FDA 510(k) clearance for the SAVE GBR, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 7, 2023, 176 days after receiving the submission on August 15, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K222451 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2022
Decision Date	February 07, 2023
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.