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GLASION

FDA 510(k)

Class II (US FDA 510(k))

510(k) K895386

by Scientific Pharmaceuticals, Inc.

Identifiers

510(k) Number
K895386 FDA 510(k)
FDA Product Code
EMA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

GLASION is a dental cement used for dental applications. It is a Class II medical device that serves as a cement in dental procedures.

GLASION is supplied by Scientific Pharmaceuticals, Inc. and is regulated under FDA 510(k) clearance with product code EMA. The device is classified under regulation 872.3275 and received FDA clearance on April 16, 1990.

Frequently asked questions

What is GLASION used for in dental procedures?

GLASION is a dental cement used for various dental applications. It serves as a cement material in dental procedures, providing a reliable bonding solution for dental restorations and other treatments.

How is GLASION supplied and what is its regulatory status?

GLASION is supplied by Scientific Pharmaceuticals, Inc. It is a Class II medical device regulated under FDA 510(k) clearance with product code EMA, receiving clearance on April 16, 1990.

Is GLASION single-use or reusable?

The device data does not specify whether GLASION is designed for single-use or reuse. Clinicians should refer to the product instructions for use to determine the appropriate handling and disposal procedures for this dental cement.

What are the storage requirements for GLASION?

The device data does not provide specific storage requirements for GLASION. Users should follow the manufacturer's instructions for proper storage conditions to maintain the product's integrity and effectiveness.

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: K895386 FDA 510(k) - GLASION | Scientific Pharmaceuticals, Inc., GLASION 510 (k) K895386 - FDA.report, GLASION (K895386) — FDA 510 (k) | Innolitics, Welcome to Sci-Pharm

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) K895386 24 fields · synced Sep 26, 2026