Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Pulpdent Corporation. It received FDA 510(k) clearance on 2018-01-05 under approval 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. It is manufactured by Pulpdent Corporation. The 510(k) number is K172169.

When was Pulpdent (Activa) Pit and Fissure Sealant with MCP approved by the FDA?

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

What company makes Pulpdent (Activa) Pit and Fissure Sealant with MCP?

Pulpdent (Activa) Pit and Fissure Sealant with MCP is manufactured by Pulpdent Corporation.

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.

Other Devices by Pulpdent Corporation

K153249Pulpdent Solo Flowable Composite with MCP K173020OBA-MCP, Orthodontic Bracket Adhesive with MCP K210045ACTIVA PRESTO PACK

Related Devices (Code: EBC)

K161580Premier SealantPremier Dental Company Products K171330Nanova SealantNanova Biomaterials, Inc. K162598HAPI SealBisco, Inc. K190998BA Pit & Fissure SealantApex Dental Materials, Inc. K190339Helioseal F PlusIvoclar Vivadent, AG K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, 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.

↑