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FDA 510(k)

ARTIFICIAL TEETH (ACRYLIC TEETH)

K-Number: K992854 · 2000-02-07

ApplicantMasterdent Ltda.
Decision Date2000-02-07
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARTIFICIAL TEETH (ACRYLIC TEETH) is the device name listed in this FDA 510(k) record. The listed applicant is Masterdent Ltda.. It received FDA 510(k) clearance on 2000-02-07 under 510(k) number K992854. 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 ARTIFICIAL TEETH (ACRYLIC TEETH)?

ARTIFICIAL TEETH (ACRYLIC TEETH) is a medical device that received FDA 510(k) clearance on 2000-02-07. The listed applicant is Masterdent Ltda.. The 510(k) number is K992854.

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

ARTIFICIAL TEETH (ACRYLIC TEETH) received FDA 510(k) clearance on 2000-02-07, under 510(k) number K992854.

Who is the listed applicant for ARTIFICIAL TEETH (ACRYLIC TEETH)?

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

What is the FDA product code for ARTIFICIAL TEETH (ACRYLIC TEETH)?

The FDA product code for ARTIFICIAL TEETH (ACRYLIC TEETH) is ELM.

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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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

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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