510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905321Substantially Equivalent

Platinum Foil, Various Sizes

Ivoclar North America, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905321 is the FDA 510(k) clearance record for PLATINUM FOIL, VARIOUS SIZES, a class II device, cleared for Ivoclar North America, Inc. on under FDA product code EIH (Powder, Porcelain). FDA records list 131 510(k) clearances for Ivoclar North America, Inc., from to . As of , FDA records show no recalls naming K905321.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Ivoclar North America, Inc. 175 Pineview Dr., Amherst NY
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