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FDA 510(k)

DENTURE PRODUCT X

K-Number: K914257 · 1993-01-13

ApplicantEssential Dental Systems, Inc.
Decision Date1993-01-13
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTURE PRODUCT X is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 1993-01-13 under 510(k) number K914257. 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 DENTURE PRODUCT X?

DENTURE PRODUCT X is a medical device that received FDA 510(k) clearance on 1993-01-13. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K914257.

When did DENTURE PRODUCT X receive FDA 510(k) clearance?

DENTURE PRODUCT X received FDA 510(k) clearance on 1993-01-13, under 510(k) number K914257.

Who is the listed applicant for DENTURE PRODUCT X?

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

What is the FDA product code for DENTURE PRODUCT X?

The FDA product code for DENTURE PRODUCT X is EFT.

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Other records listing Essential Dental Systems, Inc. as applicant

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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 GmbHK925259CFR MONOGRAPHCombe, 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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