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FDA 510(k)

CONDYLAFORM II NFC

K-Number: K060565 · 2006-05-08

ApplicantIvoclar Vivadent, Inc.
Decision Date2006-05-08
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONDYLAFORM II NFC is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2006-05-08 under 510(k) number K060565. 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 CONDYLAFORM II NFC?

CONDYLAFORM II NFC is a medical device that received FDA 510(k) clearance on 2006-05-08. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K060565.

When did CONDYLAFORM II NFC receive FDA 510(k) clearance?

CONDYLAFORM II NFC received FDA 510(k) clearance on 2006-05-08, under 510(k) number K060565.

Who is the listed applicant for CONDYLAFORM II NFC?

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

What is the FDA product code for CONDYLAFORM II NFC?

The FDA product code for CONDYLAFORM II NFC is ELM.

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Other records listing Ivoclar Vivadent, 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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