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Sci-Pharm Post Secure

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013555

by Scientific Pharmaceuticals, Inc.

Identifiers

510(k) Number
K013555 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)

The Sci-Pharm Post Secure is a dental cement, classified under the nomenclature for dental materials used to secure orthodontic appliances or brackets to teeth. It is designed to provide a durable bond in restorative and orthodontic procedures, ensuring stability during treatment.

This product is supplied as a reusable, non-sterile material intended for use in dental settings. It is regulated under FDA 510(k) clearance (K013555) and falls under regulation number 872.3275 for dental cements. Multiple lot or batch codes are associated with its distribution, though specific storage conditions or MRI safety information are not detailed in the provided data.

Frequently asked questions

Is the Sci-Pharm Post Secure intended for single-use or can it be reused in multiple procedures?

The Sci-Pharm Post Secure is explicitly described as a reusable dental cement. Since it is non-sterile and supplied for use in dental settings, it is meant to be used across multiple procedures after proper cleaning and handling, rather than being discarded after a single application.

What types of dental procedures is the Sci-Pharm Post Secure primarily used for?

This product is classified under dental materials for securing orthodontic appliances or brackets to teeth. It is designed to provide a durable bond in restorative and orthodontic procedures, ensuring stability during treatment. It is not intended for general filling or structural repair but specifically for affixing orthodontic hardware.

How should the Sci-Pharm Post Secure be stored, and are there any special handling requirements?

The provided data does not specify exact storage conditions (e.g., temperature, humidity), but since it is non-sterile and reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper labeling and tracking of lot/batch codes are recommended for inventory management, as multiple lot numbers are associated with its distribution.

What regulatory pathway was followed for FDA clearance of the Sci-Pharm Post Secure?

The Sci-Pharm Post Secure received FDA 510(k) clearance under the classification for dental cements (regulation number 872.3275). The submission was filed as a Traditional 510(k) and was determined to be substantially equivalent to a predicate device. The decision was made by the Dental (DE) Advisory Committee on January 23, 2002, following receipt of the application on October 25, 2001.

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: SCI-PHARM POST SECURE (K013555) — FDA 510 (k) | Innolitics, Welcome to Sci-Pharm, 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) K013555 24 fields · synced Sep 19, 2026