Identifiers
- 510(k) Number
- K031212 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)
This device is a Dental Cement, Temporary (per FDA classification K031212), designed to provide a provisional bond for dental restorations. It is a resin-based material formulated to secure temporary crowns, bridges, or other dental prosthetics while awaiting permanent fixation. The cement adheres to tooth structures and restorative materials, ensuring stability during the interim period.
The Temporary Resin Cement is supplied as a dual-cure resin system in an automix syringe (e.g., 5 mL or 1 mL) with mixing tips, intended for single-use in clinical settings. It is classified as a Class II medical device under FDA regulation 872.3275 and has received FDA 510K clearance as substantially equivalent to predicate devices. Sterility and handling instructions are manufacturer-specific, and use requires adherence to dental infection control protocols. The device is not MRI-safe unless explicitly stated in updated labeling.
Frequently asked questions
What is the Temporary Resin Cement used for?
The Temporary Resin Cement is designed to provide a provisional bond for dental restorations, specifically securing temporary crowns, bridges, or other dental prosthetics. It adheres to tooth structures and restorative materials, ensuring stability during the interim period before permanent fixation.
How is the Temporary Resin Cement supplied and intended for use?
This cement is supplied as a dual-cure resin system in automix syringes (available in 5 mL or 1 mL sizes) with mixing tips. It is intended for single-use in clinical settings, adhering to dental infection control protocols to maintain safety and sterility.
Is the Temporary Resin Cement sterile and reusable?
The Temporary Resin Cement is not described as sterile in the provided data, so sterility handling instructions are manufacturer-specific. It is explicitly intended for single-use only, meaning each syringe should not be reused after application.
What sizes or models of the Temporary Resin Cement are available?
The device is supplied in automix syringes with two primary sizes: 5 mL and 1 mL. The syringes include mixing tips tailored for clinical precision. No additional models or variations are mentioned in the provided data.
How should the Temporary Resin Cement be stored, and are there any special considerations?
Storage instructions are manufacturer-specific, but the device is intended for clinical use in controlled environments. Since it is a single-use product, it should be stored according to the manufacturer’s guidelines to preserve its integrity until use. Additionally, the cement is not MRI-safe unless explicitly stated in updated labeling.
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: E.T.C.™ Easy Temporary Cement - Parkell Inc., E.T.C.™ Easy Temporary Cement - Parkell Inc., Top Parkell ETC Cement | Sky Dental Supply, Parkell E.T.C. Easy Temporary Cement (1mL-Syringe)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031212 | Class II | Active |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (1)
- FDA 510(k) K031212 24 fields · synced Oct 1, 2026