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Curay Join Dent Dentin Primer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K850675

by Scientific Pharmaceuticals, Inc.

Identifiers

510(k) Number
K850675 FDA 510(k)
FDA Product Code
EBD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3310 FDA 510(k)
Regulation Number
872.3310 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Curay Join Dent Dentin Primer is a dental Coating, Filling Material, and Resin designed as an intermediate layer between enamel or dentin and restorative materials or cements. It functions to enhance bonding to tooth structure, reduce marginal leakage, and minimize tooth sensitivity during restorative procedures.

This product is supplied as a single-use dental adhesive and is classified under FDA regulation number 872.3310 as a Class II device, with a Traditional 510(k) clearance (K850675). It is intended for use in dental settings and is not sterile at the point of sale; sterilization instructions must be followed per manufacturer guidelines. The device is distributed by Scientific Pharmaceuticals, Inc., and adheres to FDA dental advisory committee standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Curay Join Dent Dentin Primer 510 (k) FDA Premarket Notification ..., Device Listing 1516966653 - FDA.report, Welcome to Sci-Pharm, Welcome to Sci-Pharm, 510 (k) K850675 — CURAY JOIN DENT DENTIN PRIMER — RegDataLab

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Scientific Pharmaceuticals, Inc.

Sources (1)

  • FDA 510(k) K850675 24 fields · synced Sep 19, 2026