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FDA 510(k)

SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH

K-Number: K962456 · 1996-08-06

ApplicantIvoclar North America, Inc.
Decision Date1996-08-06
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1996-08-06 under 510(k) number K962456. 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 SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH?

SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K962456.

When did SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH receive FDA 510(k) clearance?

SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH received FDA 510(k) clearance on 1996-08-06, under 510(k) number K962456.

Who is the listed applicant for SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH?

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

What is the FDA product code for SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH?

The FDA product code for SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR 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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Other records listing Ivoclar North America, Inc. 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

View all 131 devices →

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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