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FDA 510(k)

Pulpdent (Activa) Pit and Fissure Sealant with MCP

K-Number: K172169 · 2018-01-05

ApplicantPulpdent Corporation
Decision Date2018-01-05
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pulpdent (Activa) Pit and Fissure Sealant with MCP is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K172169. 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 Pulpdent (Activa) Pit and Fissure Sealant with MCP?

Pulpdent (Activa) Pit and Fissure Sealant with MCP is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Pulpdent Corporation. The 510(k) number is K172169.

When did Pulpdent (Activa) Pit and Fissure Sealant with MCP receive FDA 510(k) clearance?

Pulpdent (Activa) Pit and Fissure Sealant with MCP received FDA 510(k) clearance on 2018-01-05, under 510(k) number K172169.

Who is the listed applicant for Pulpdent (Activa) Pit and Fissure Sealant with MCP?

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 (Activa) Pit and Fissure Sealant with MCP?

The FDA product code for Pulpdent (Activa) Pit and Fissure Sealant with MCP is EBC.

Related Clinical Trials

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.

NCT07725133Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional PolishingNOT_YET_RECRUITING

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.

K210045ACTIVA PRESTO PACKK173020OBA-MCP, Orthodontic Bracket Adhesive with MCPK153249Pulpdent Solo Flowable Composite with MCP

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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