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FDA 510(k)

DENTURE PLASTIC TEETH,76 ELM

K-Number: K915276 · 1992-02-03

ApplicantNobelpharma USA, Inc.
Decision Date1992-02-03
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTURE PLASTIC TEETH,76 ELM is the device name listed in this FDA 510(k) record. The listed applicant is Nobelpharma USA, Inc.. It received FDA 510(k) clearance on 1992-02-03 under 510(k) number K915276. 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 DENTURE PLASTIC TEETH,76 ELM?

DENTURE PLASTIC TEETH,76 ELM is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K915276.

When did DENTURE PLASTIC TEETH,76 ELM receive FDA 510(k) clearance?

DENTURE PLASTIC TEETH,76 ELM received FDA 510(k) clearance on 1992-02-03, under 510(k) number K915276.

Who is the listed applicant for DENTURE PLASTIC TEETH,76 ELM?

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

What is the FDA product code for DENTURE PLASTIC TEETH,76 ELM?

The FDA product code for DENTURE PLASTIC TEETH,76 ELM is ELM.

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Other records listing Nobelpharma USA, Inc. as applicant

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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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