510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950518Substantially Equivalent

Miele G 7781 Dental Thermal Disinfector

Miele Professional, Somerset NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950518 is the FDA 510(k) clearance record for MIELE G 7781 DENTAL THERMAL DISINFECTOR, a class II device, cleared for Miele Professional on under FDA product code LDS (Device, Pasteurization, Hot Water). FDA records list one 510(k) clearance for Miele Professional. As of , FDA records show no recalls naming K950518.

Clearance record

Decision date
Received
(354 days to decision)
Product code
LDS Device, Pasteurization, Hot Water
Regulation
21 CFR 880.6991
Device class
Class II
Review panel
General Hospital
Applicant
Miele Professional 22 D Worlds Fair Dr., Somerset NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LDS

Trailing 12 months

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

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