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FDA 510(k)

PULPDENT GLAZE

K-Number: K020432 · 2002-04-17

ApplicantPulpdent Corporation
Decision Date2002-04-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT GLAZE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2002-04-17 under 510(k) number K020432. 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 PULPDENT GLAZE?

PULPDENT GLAZE is a medical device that received FDA 510(k) clearance on 2002-04-17. The listed applicant is Pulpdent Corporation. The 510(k) number is K020432.

When did PULPDENT GLAZE receive FDA 510(k) clearance?

PULPDENT GLAZE received FDA 510(k) clearance on 2002-04-17, under 510(k) number K020432.

Who is the listed applicant for PULPDENT GLAZE?

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

What is the FDA product code for PULPDENT GLAZE?

The FDA product code for PULPDENT GLAZE is EBF.

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Other records listing Pulpdent Corporation 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.

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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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