510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K152861Substantially Equivalent

Aquasil Ultra + Smart Wetting Impression Material

Dentply International, Inc., York PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152861 is the FDA 510(k) clearance record for Aquasil Ultra + Smart Wetting Impression Material, a class II device, cleared for Dentply International, Inc. on under FDA product code ELW (Material, Impression). FDA records list one 510(k) clearance for Dentply International, Inc. As of , FDA records show no recalls naming K152861.

Clearance record

Decision date
Received
(156 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Dentply International, Inc. 221 W. Philadelphia St., Suite 60, York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260