510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K041834Substantially Equivalent

Adr Plus Ssxi Imaging Device for X-Ray Systems Such as X-Caliber, X-Caliber Cm, Ana-Bel and Ana-Bel Cm

Takara Belmont USA, Inc., West Cadwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041834 is the FDA 510(k) clearance record for ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM, a class II device, cleared for Takara Belmont USA, Inc. on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list 6 510(k) clearances for Takara Belmont USA, Inc., from to . As of , FDA records show no recalls naming K041834.

Clearance record

Decision date
Received
(149 days to decision)
Product code
MUH System, X-Ray, Extraoral Source, Digital
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Takara Belmont USA, Inc. 1129 Bloomfield Ave., West Cadwell NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MUH

Trailing 12 months
2 clearances under product code MUH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260