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FDA 510(k)

PRIMODENT ACRYLIC TEETH

K-Number: K926070 · 1994-02-17

ApplicantI.T.C. Ent.
Decision Date1994-02-17
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIMODENT ACRYLIC TEETH is the device name listed in this FDA 510(k) record. The listed applicant is I.T.C. Ent.. It received FDA 510(k) clearance on 1994-02-17 under 510(k) number K926070. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMODENT ACRYLIC TEETH?

PRIMODENT ACRYLIC TEETH is a medical device that received FDA 510(k) clearance on 1994-02-17. The listed applicant is I.T.C. Ent.. The 510(k) number is K926070.

When did PRIMODENT ACRYLIC TEETH receive FDA 510(k) clearance?

PRIMODENT ACRYLIC TEETH received FDA 510(k) clearance on 1994-02-17, under 510(k) number K926070.

Who is the listed applicant for PRIMODENT ACRYLIC TEETH?

The FDA 510(k) record lists I.T.C. Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMODENT ACRYLIC TEETH?

The FDA product code for PRIMODENT ACRYLIC TEETH is ELM.

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Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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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