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FDA 510(k)

HELIOMOLAR HB TRANSLUCENT SHADES

K-Number: K013929 · 2002-02-07

ApplicantIvoclar Vivadent, Inc.
Decision Date2002-02-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIOMOLAR HB TRANSLUCENT SHADES 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 2002-02-07 under 510(k) number K013929. 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 HELIOMOLAR HB TRANSLUCENT SHADES?

HELIOMOLAR HB TRANSLUCENT SHADES is a medical device that received FDA 510(k) clearance on 2002-02-07. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K013929.

When did HELIOMOLAR HB TRANSLUCENT SHADES receive FDA 510(k) clearance?

HELIOMOLAR HB TRANSLUCENT SHADES received FDA 510(k) clearance on 2002-02-07, under 510(k) number K013929.

Who is the listed applicant for HELIOMOLAR HB TRANSLUCENT SHADES?

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 HELIOMOLAR HB TRANSLUCENT SHADES?

The FDA product code for HELIOMOLAR HB TRANSLUCENT SHADES is EBF.

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Other records listing Ivoclar Vivadent, Inc. as applicant

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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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