510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K951582Substantially Equivalent

Ultradent Porcelain Etch

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

K951582 is the FDA 510(k) clearance record for ULTRADENT PORCELAIN ETCH, a class II device, cleared for Ultradent Products, Inc. on under FDA product code EIH (Powder, Porcelain). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K951582.

Clearance record

Decision date
Received
(34 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Ultradent Products, Inc. 505 W. 10200 S., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code EIH

Trailing 12 months
15 clearances under product code EIH in the twelve months to November 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EIH, trailing twelve months
MonthClearances
December 20251
January 20262
February 20260
March 20262
April 20261
May 20261
June 20263
July 20262
August 20261
September 20260
October 20262
November 20260