510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810525Substantially Equivalent

Sr-Ivotray Universal

J. Aderer, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810525 is the FDA 510(k) clearance record for SR-IVOTRAY UNIVERSAL, a class I device, cleared for J. Aderer, Inc. on under FDA product code EHY (Tray, Impression, Preformed). FDA records list 24 510(k) clearances for J. Aderer, Inc., from to . As of , FDA records show no recalls naming K810525.

Clearance record

Decision date
Received
(19 days to decision)
Product code
EHY Tray, Impression, Preformed
Regulation
21 CFR 872.6880
Device class
Class I
Review panel
Dental
Applicant
J. Aderer, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EHY

Trailing 12 months

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

FDA records show no clearances under product code EHY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EHY, 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