510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K222891Substantially Equivalent

Dental Desensitizer

Guangzhou Beogene Biotech Co., Ltd., Guangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222891 is the FDA 510(k) clearance record for Dental Desensitizer, a class II device, cleared for Guangzhou Beogene Biotech Co., Ltd. on under FDA product code LBH (Varnish, Cavity). FDA records list one 510(k) clearance for Guangzhou Beogene Biotech Co., Ltd. As of , FDA records show no recalls naming K222891.

Clearance record

Decision date
Received
(244 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Guangzhou Beogene Biotech Co., Ltd. Second Floor, Bldg. C, Self-Compiled (1) Bldg., Guangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBH

Trailing 12 months
6 clearances under product code LBH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260