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FDA 510(k)

SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS

K-Number: K844349 · 1984-12-03

ApplicantIvoclar USA, Inc.
Decision Date1984-12-03
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar USA, Inc.. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K844349. 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 VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS?

SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Ivoclar USA, Inc.. The 510(k) number is K844349.

When did SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS receive FDA 510(k) clearance?

SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS received FDA 510(k) clearance on 1984-12-03, under 510(k) number K844349.

Who is the listed applicant for SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS?

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

What is the FDA product code for SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS?

The FDA product code for SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS is ELM.

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Other records listing Ivoclar USA, 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.

K012877HIGH GOLD PALLADIUM FREE CERAMIC SOLDERK981264ARISTON PHCK980986PROCADK941849PROVIPONT C&BK923644DW243-64K864708SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN

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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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