510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K782153Substantially Equivalent

Impression Tray, Mdds Custom

Chayet and Sonnenrich, P.C., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K782153 is the FDA 510(k) clearance record for IMPRESSION TRAY, MDDS CUSTOM, a class I device, cleared for Chayet and Sonnenrich, P.C. on under FDA product code EBH (Material, Impression Tray, Resin). FDA records list one 510(k) clearance for Chayet and Sonnenrich, P.C. As of , FDA records show no recalls naming K782153.

Clearance record

Decision date
Received
(62 days to decision)
Product code
EBH Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Applicant
Chayet and Sonnenrich, P.C. 4221 Richmond Rd., NW, Walker MI
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