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FDA 510(k)

PRE-KLENE ENAMEL CLEANER

K-Number: K844572 · 1985-01-18

ApplicantMedical Products Laboratories, Inc.
Decision Date1985-01-18
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRE-KLENE ENAMEL CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products Laboratories, Inc.. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K844572. The device is classified under product code EFT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-KLENE ENAMEL CLEANER?

PRE-KLENE ENAMEL CLEANER is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Medical Products Laboratories, Inc.. The 510(k) number is K844572.

When did PRE-KLENE ENAMEL CLEANER receive FDA 510(k) clearance?

PRE-KLENE ENAMEL CLEANER received FDA 510(k) clearance on 1985-01-18, under 510(k) number K844572.

Who is the listed applicant for PRE-KLENE ENAMEL CLEANER?

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

What is the FDA product code for PRE-KLENE ENAMEL CLEANER?

The FDA product code for PRE-KLENE ENAMEL CLEANER is EFT.

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 Medical Products Laboratories, 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.

K040098VARNISHAMERICA

Related Devices (Code: EFT)

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.

K080631CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSEROral Health Technologies, LLCK051342MEDICAL INTERPOROUSBonyf AGK000996TRUBYTE DENTURE CLEANSER/POLISHING COMPOUNDDentsply Intl.K942203OTC DENTURE CLEANSERCombe, Inc.K930337PROFAST(R)-DENTURE CLEANSERFittydent-Altwirth & Schmitt GmbHK914257DENTURE PRODUCT XEssential Dental Systems, Inc.

Official Source

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

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