510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863421Substantially Equivalent

Sr-Ivolen Tray Material

Ivoclar USA, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863421 is the FDA 510(k) clearance record for SR-IVOLEN TRAY MATERIAL, a class I device, cleared for Ivoclar USA, Inc. on under FDA product code EBH (Material, Impression Tray, Resin). FDA records list 11 510(k) clearances for Ivoclar USA, Inc., from to . As of , FDA records show no recalls naming K863421.

Clearance record

Decision date
Received
(60 days to decision)
Product code
EBH Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Applicant
Ivoclar USA, Inc. Bauer, Cheng & Associates, Chicago IL
Third party review
No

Clearances, product code EBH

Trailing 12 months

FDA records hold no clearances under product code EBH in the trailing twelve months.

FDA records show no clearances under product code EBH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EBH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260