510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K152652Substantially Equivalent

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

Gaia Dental Products, Inc., Meriden CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152652 is the FDA 510(k) clearance record for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement, a class II device, cleared for Gaia Dental Products, Inc. on under FDA product code EMA (Cement, Dental). FDA records list one 510(k) clearance for Gaia Dental Products, Inc. As of , FDA records show no recalls naming K152652.

Clearance record

Decision date
Received
(202 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Gaia Dental Products, Inc. 290 Pratt St., Unit 2314, Meriden CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EMA

Trailing 12 months
10 clearances under product code EMA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EMA, trailing twelve months
MonthClearances
November 20250
December 20253
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20261
August 20262
September 20261
October 20260