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FDA 510(k)

ARISTON PHC

K-Number: K981264 · 1998-07-02

ApplicantIvoclar USA, Inc.
Decision Date1998-07-02
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARISTON PHC 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 1998-07-02 under 510(k) number K981264. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARISTON PHC?

ARISTON PHC is a medical device that received FDA 510(k) clearance on 1998-07-02. The listed applicant is Ivoclar USA, Inc.. The 510(k) number is K981264.

When did ARISTON PHC receive FDA 510(k) clearance?

ARISTON PHC received FDA 510(k) clearance on 1998-07-02, under 510(k) number K981264.

Who is the listed applicant for ARISTON PHC?

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 ARISTON PHC?

The FDA product code for ARISTON PHC is EBF.

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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 SOLDERK980986PROCADK941849PROVIPONT C&BK923644DW243-64K864708SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESINK864710ISOSIT N

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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