510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K133206Substantially Equivalent

Z-Ray Intra-Oral Digital Radiography System

Zuma Dental, LLC, Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133206 is the FDA 510(k) clearance record for Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM, a class II device, cleared for Zuma Dental, LLC on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list one 510(k) clearance for Zuma Dental, LLC. As of , FDA records show no recalls naming K133206.

Clearance record

Decision date
Received
(208 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
Zuma Dental, LLC 27001 La Paz Rd., Mission Viejo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUH

Trailing 12 months
3 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 20261
October 20260