510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222367Substantially Equivalent

Save Gbr

Dentis Co.,Ltd, Daegu, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222367 is the FDA 510(k) clearance record for SAVE GBR, a class II device, cleared for Dentis Co., Ltd. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 37 510(k) clearances for Dentis Co., Ltd., from to . As of , FDA records show no recalls naming K222367.

Clearance record

Decision date
Received
(230 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Dentis Co., Ltd. 99, Seongseoseo-Ro, Daegu, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZL

Trailing 12 months
1 clearance under product code DZL in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260