510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844034Substantially Equivalent

Sonocare

Echo Ultrasound, Lewistown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844034 is the FDA 510(k) clearance record for SONOCARE, a class I device, cleared for Echo Ultrasound on under FDA product code DYO (Band, Material, Orthodontic). FDA records list 6 510(k) clearances for Echo Ultrasound, from to . As of , FDA records show no recalls naming K844034.

Clearance record

Decision date
Received
(99 days to decision)
Product code
DYO Band, Material, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Echo Ultrasound Post Office Box 552, Lewistown PA
Third party review
No

Clearances, product code DYO

Trailing 12 months

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

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