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
K990087Substantially Equivalent

Dmd Digital X-Ray System

Dental/Medical Diagnostic Systems, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990087 is the FDA 510(k) clearance record for DMD DIGITAL X-RAY SYSTEM, a class II device, cleared for Dental/Medical Diagnostic Systems, Inc. on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list 3 510(k) clearances for Dental/Medical Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K990087.

Clearance record

Decision date
Received
(122 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
Dental/Medical Diagnostic Systems, Inc. 16722 Millikan Ave., Irvine CA
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