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FDA 510(k)

DENTITION INTEGRATING MATERIAL

K-Number: K020287 · 2002-04-12

ApplicantPulpdent Corporation
Decision Date2002-04-12
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTITION INTEGRATING MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2002-04-12 under 510(k) number K020287. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTITION INTEGRATING MATERIAL?

DENTITION INTEGRATING MATERIAL is a medical device that received FDA 510(k) clearance on 2002-04-12. The listed applicant is Pulpdent Corporation. The 510(k) number is K020287.

When did DENTITION INTEGRATING MATERIAL receive FDA 510(k) clearance?

DENTITION INTEGRATING MATERIAL received FDA 510(k) clearance on 2002-04-12, under 510(k) number K020287.

Who is the listed applicant for DENTITION INTEGRATING MATERIAL?

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 DENTITION INTEGRATING MATERIAL?

The FDA product code for DENTITION INTEGRATING MATERIAL is EBC.

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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: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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