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FDA 510(k)

STERI-DENT, STERI-SURE

K-Number: K094026 · 2011-07-12

ApplicantCpac, Inc.
Decision Date2011-07-12
Product CodeKMH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERI-DENT, STERI-SURE is the device name listed in this FDA 510(k) record. The listed applicant is Cpac, Inc.. It received FDA 510(k) clearance on 2011-07-12 under 510(k) number K094026. 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 STERI-DENT, STERI-SURE?

STERI-DENT, STERI-SURE is a medical device that received FDA 510(k) clearance on 2011-07-12. The listed applicant is Cpac, Inc.. The 510(k) number is K094026.

When did STERI-DENT, STERI-SURE receive FDA 510(k) clearance?

STERI-DENT, STERI-SURE received FDA 510(k) clearance on 2011-07-12, under 510(k) number K094026.

Who is the listed applicant for STERI-DENT, STERI-SURE?

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

What is the FDA product code for STERI-DENT, STERI-SURE?

The FDA product code for STERI-DENT, STERI-SURE is KMH.

Related Clinical Trials

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.

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Other records listing Cpac, 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.

K110867STERI-DENT, STERI-SUREK781486STERI-VAC POWER UNITSK771071PORTO-VACK771070DRY HEAT STERILIZER

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.

K051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMColtene/Whaledent, 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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