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FDA 510(k)

TOOTH SHADE RESIN MATERIAL

K-Number: K011453 · 2001-07-23

ApplicantRite-Dent Manufacturing Corp.
Decision Date2001-07-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOOTH SHADE RESIN MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Rite-Dent Manufacturing Corp.. It received FDA 510(k) clearance on 2001-07-23 under 510(k) number K011453. 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 TOOTH SHADE RESIN MATERIAL?

TOOTH SHADE RESIN MATERIAL is a medical device that received FDA 510(k) clearance on 2001-07-23. The listed applicant is Rite-Dent Manufacturing Corp.. The 510(k) number is K011453.

When did TOOTH SHADE RESIN MATERIAL receive FDA 510(k) clearance?

TOOTH SHADE RESIN MATERIAL received FDA 510(k) clearance on 2001-07-23, under 510(k) number K011453.

Who is the listed applicant for TOOTH SHADE RESIN MATERIAL?

The FDA 510(k) record lists Rite-Dent Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOOTH SHADE RESIN MATERIAL?

The FDA product code for TOOTH SHADE RESIN MATERIAL is EBF.

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Other records listing Rite-Dent Manufacturing Corp. as applicant

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Related Devices (Code: EBF)

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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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