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FDA 510(k)

DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM

K-Number: K051660 · 2005-08-04

ApplicantColtene/Whaledent, Inc.
Decision Date2005-08-04
Product CodeKMH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 2005-08-04 under 510(k) number K051660. The device is classified under product code KMH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM?

DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K051660.

When did DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM receive FDA 510(k) clearance?

DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM received FDA 510(k) clearance on 2005-08-04, under 510(k) number K051660.

Who is the listed applicant for DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM?

The FDA 510(k) record lists Coltene/Whaledent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM?

The FDA product code for DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM is KMH.

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Other records listing Coltene/Whaledent, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071632PERFECT TISSUE CONTOURING SYSTEM IIK040551COLTOLUX LED CURING LIGHTK033760ONE COAT SE BONDK031752COLTOSOL FK013400SYNERGY FLOWK003034COLTENE AURA COMPOMER RESTORATIVE SYSTEM

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Related Devices (Code: KMH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K094026STERI-DENT, STERI-SURECpac, Inc.K910925DISINFECTION WITH THE COX DRY HEAT STERILIZERCox Sterile Products, Inc.K910202DENTRONIX MODEL 2000Dentronix, Inc.K880322DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMDentronix, Inc.K881371COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLECox Sterile Products, Inc.K872643COX RAPID HEAT TRANSFER STERILIZERCox Sterile Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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