510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942668Substantially Equivalent

O-Tray Impression Trays

Dentauraum, Inc., Newtown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942668 is the FDA 510(k) clearance record for O-TRAY IMPRESSION TRAYS, a class I device, cleared for Dentauraum, Inc. on under FDA product code EHY (Tray, Impression, Preformed). FDA records list 24 510(k) clearances for Dentauraum, Inc., from to . As of , FDA records show no recalls naming K942668.

Clearance record

Decision date
Received
(46 days to decision)
Product code
EHY Tray, Impression, Preformed
Regulation
21 CFR 872.6880
Device class
Class I
Review panel
Dental
Applicant
Dentauraum, Inc. 10 Pheasant Run, Newtown PA
510(k) summary
Statement
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