Dentronix

FDA UDI

Class II (US FDA UDI)

by Dentronix, Inc.

Identity

Trade Name: Dentronix FDA UDI
Generic Name: Dry-heat sterilizer FDA UDI
Device Name: Accessory Kit for DDS7000 FDA UDI
Model / Reference: D7107-01 FDA UDI
Description: Accessory Kit for DDS7000 FDA UDI

Identifiers

Primary DI / UDI-DI: D661D7107010 FDA UDI
510(k) Number: K051660 FDA UDI
FDA Product Code: KMH FDA UDI
GMDN Term: Dry-heat sterilizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dry-heat sterilizer

Dentronix by Dentronix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dry-heat sterilizer.

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COX RAPIDHEAT — CPAC Equipment, Inc. · Class II
COX RAPIDHEAT — CPAC Equipment, Inc. · Class II
STERISURE — CPAC Equipment, Inc. · Class II
GRAFCO — GF Health Products, Inc · Class II
COX RAPIDHEAT — CPAC Equipment, Inc. · Class II
STERIDENT — CPAC Equipment, Inc. · Class II

Cleared under the same submission

K051660 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dentronix, Inc.

Sources (1)

FDA UDI d67382a2-d4a5-4dfb-aabc-88cc299ad873 35 fields · synced Jun 8, 2026