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FDA 510(k)

WIEDENT ESTETIC

K-Number: K061337 · 2006-06-07

ApplicantXpdent Corp
Decision Date2006-06-07
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WIEDENT ESTETIC is the device name listed in this FDA 510(k) record. The listed applicant is Xpdent Corp. It received FDA 510(k) clearance on 2006-06-07 under 510(k) number K061337. 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 WIEDENT ESTETIC?

WIEDENT ESTETIC is a medical device that received FDA 510(k) clearance on 2006-06-07. The listed applicant is Xpdent Corp. The 510(k) number is K061337.

When did WIEDENT ESTETIC receive FDA 510(k) clearance?

WIEDENT ESTETIC received FDA 510(k) clearance on 2006-06-07, under 510(k) number K061337.

Who is the listed applicant for WIEDENT ESTETIC?

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

What is the FDA product code for WIEDENT ESTETIC?

The FDA product code for WIEDENT ESTETIC is ELM.

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Other records listing Xpdent Corp as applicant

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.

K082158DENSEO FAIRYK071201ZEO CE LIGHT & ZEO QUICK PORCELAIN

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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