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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
Long Handle Combo Rack FDA UDI
Model / Reference
D7000CL FDA UDI
Description
Long Handle Combo Rack FDA UDI

Identifiers

Primary DI / UDI-DI
D661D7000CL0 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dry-heat sterilizer

A comprehensive medical device for total elimination and/or inactivation of microorganisms from non-heat sensitive medical devices and related products using dry heat sterilization.

Similar devices

Also classified as Dry-heat sterilizer.

Cleared under the same submission

K051660 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentronix, Inc.

Sources (1)

  • FDA UDI 4e38a85a-87d2-4128-9244-38b542f5894e 35 fields · synced Jul 30, 2026