510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161891Substantially Equivalent

HC Primer

Shofu Dental Corp., San Marcos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161891 is the FDA 510(k) clearance record for HC Primer, a class II device, cleared for Shofu Dental Corporation on under FDA product code KLE (Agent, Tooth Bonding, Resin). FDA records list 97 510(k) clearances for Shofu Dental Corporation, from to . As of , FDA records show no recalls naming K161891.

Clearance record

Decision date
Received
(133 days to decision)
Product code
KLE Agent, Tooth Bonding, Resin
Regulation
21 CFR 872.3200
Device class
Class II
Review panel
Dental
Applicant
Shofu Dental Corporation 1225 Stone Dr., San Marcos CA
510(k) summary
Statement
Third party review
No

Clearances, product code KLE

Trailing 12 months
8 clearances under product code KLE in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KLE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20261
March 20262
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260