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FDA 510(k)

QUADRANT ANTERIOR SHINE

K-Number: K983549 · 1998-11-23

ApplicantCavex Holland BV
Decision Date1998-11-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUADRANT ANTERIOR SHINE is the device name listed in this FDA 510(k) record. The listed applicant is Cavex Holland BV. It received FDA 510(k) clearance on 1998-11-23 under 510(k) number K983549. 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 QUADRANT ANTERIOR SHINE?

QUADRANT ANTERIOR SHINE is a medical device that received FDA 510(k) clearance on 1998-11-23. The listed applicant is Cavex Holland BV. The 510(k) number is K983549.

When did QUADRANT ANTERIOR SHINE receive FDA 510(k) clearance?

QUADRANT ANTERIOR SHINE received FDA 510(k) clearance on 1998-11-23, under 510(k) number K983549.

Who is the listed applicant for QUADRANT ANTERIOR SHINE?

The FDA 510(k) record lists Cavex Holland BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUADRANT ANTERIOR SHINE?

The FDA product code for QUADRANT ANTERIOR SHINE is EBF.

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Other records listing Cavex Holland BV 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.

K073539PROVISA CEMK072245EMULATE ADVANCEDK062400IMPRESSIX, COLORCHANGE ALGINATEK061267SIMULATE, COLOR CHANGE ALGINATEK052455IMPRESSIXK051207CAVEX ORTHOTRACE

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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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