510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051660Substantially Equivalent

Dentronix Dds 7000 Rapid Dry Heat Sterilizer Sterilization System

Coltene /Whaledent AG, Cuyahoga Falls OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051660 is the FDA 510(k) clearance record for DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM, a class II device, cleared for Coltene/Whaledent, Inc. on under FDA product code KMH (Sterilizer, Dry Heat). FDA records list 39 510(k) clearances for Coltene/Whaledent, Inc., from to . As of , FDA records show no recalls naming K051660.

Clearance record

Decision date
Received
(43 days to decision)
Product code
KMH Sterilizer, Dry Heat
Regulation
21 CFR 880.6870
Device class
Class II
Review panel
General Hospital
Applicant
Coltene/Whaledent, Inc. 235 Ascot Pkwy., Cuyahoga Falls OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KMH

Trailing 12 months

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

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