510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K945451Substantially Equivalent

Hi Dense, Glass Ionomer Silver Reinforced Restorative

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

K945451 is the FDA 510(k) clearance record for HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE, a class II device, cleared for Shofu Dental Corp. on under FDA product code EMA (Cement, Dental). FDA records list 97 510(k) clearances for Shofu Dental Corp., from to . As of , FDA records show no recalls naming K945451.

Clearance record

Decision date
Received
(112 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Shofu Dental Corp. 4025 Bohannon Dr., Menlo Park CA
510(k) summary
Statement
Third party review
No

Clearances, product code EMA

Trailing 12 months
10 clearances under product code EMA in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EMA, trailing twelve months
MonthClearances
December 20253
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20261
August 20262
September 20261
October 20260
November 20260