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FDA 510(k)

SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH

K-Number: K864707 · 1987-02-10

ApplicantIvoclar USA, Inc.
Decision Date1987-02-10
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH 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 1987-02-10 under 510(k) number K864707. 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 ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH?

SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Ivoclar USA, Inc.. The 510(k) number is K864707.

When did SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH receive FDA 510(k) clearance?

SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH received FDA 510(k) clearance on 1987-02-10, under 510(k) number K864707.

Who is the listed applicant for SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH?

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 ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH?

The FDA product code for SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH 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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