510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K940860Substantially Equivalent

Chromaclone Color Changing Alginate Impress Materials

Ultradent Products Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940860 is the FDA 510(k) clearance record for CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS, a class II device, cleared for Ultradent Products, Inc. on under FDA product code ELW (Material, Impression). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K940860.

Clearance record

Decision date
Received
(93 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Ultradent Products, Inc. 505 W. 10200 So., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code ELW

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