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FDA 510(k)

NEW TOOTH MATERIAL

K-Number: K920684 · 1992-12-23

ApplicantDentsply Intl.
Decision Date1992-12-23
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEW TOOTH MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K920684. 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 NEW TOOTH MATERIAL?

NEW TOOTH MATERIAL is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Dentsply Intl.. The 510(k) number is K920684.

When did NEW TOOTH MATERIAL receive FDA 510(k) clearance?

NEW TOOTH MATERIAL received FDA 510(k) clearance on 1992-12-23, under 510(k) number K920684.

Who is the listed applicant for NEW TOOTH MATERIAL?

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

What is the FDA product code for NEW TOOTH MATERIAL?

The FDA product code for NEW TOOTH MATERIAL 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

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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