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Absolute Dentin 2

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132115

by Parkell, Inc.

Identifiers

510(k) Number
K132115 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Absolute Dentin 2 is a dental composite resin material designed for core fabrication. It is a highly filled, dual-cure composite with fluoridated barium/aluminum glass for radiopacity, providing structural support in restorative dentistry procedures.

The material is supplied in 50 ml/110 gm and 10 ml/22 gm cartridges, intended for use with an automix gun. It is intended for single-use applications in dental settings and has received FDA 510K clearance under the Dental advisory committee classification. No sterility or MRI safety information is specified.

Frequently asked questions

What is Absolute Dentin 2 used for in dental procedures?

Absolute Dentin 2 is a dental composite resin specifically designed for core fabrication, which means it provides structural support during restorative treatments. Its high fill content and dual-cure mechanism make it suitable for building up tooth structure when preparing for crowns, bridges, or other restorative work.

How is Absolute Dentin 2 supplied, and what sizes are available?

The material comes in two cartridge sizes: 50 ml/110 gm and 10 ml/22 gm. Both are intended for single-use applications and require an automix gun for dispensing, ensuring precise mixing of the two components.

Is Absolute Dentin 2 sterile, and how should it be stored?

The product is not specified as sterile, so it should be handled in a clean dental environment. Storage instructions are not detailed, but dental composites like this are typically stored in a cool, dry place away from direct sunlight to maintain material integrity.

Can Absolute Dentin 2 be reused, or is it intended for one-time use?

Absolute Dentin 2 is explicitly intended for single-use applications only. Once the cartridge is opened or used, it should be discarded to ensure proper material performance and prevent contamination.

What regulatory pathway did Absolute Dentin 2 follow to gain market authorization?

The device received FDA 510K clearance under the Dental (DE) Advisory Committee classification, with a decision labeled as *Substantially Equivalent* (SESE). This means it was determined to have the same intended use and technological characteristics as a legally marketed predicate device.

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: Absolute Dentin® Core Composite - Parkell Inc., PDF A00361revO0722_Absolute Dentin IFU-EN - Parkell, Absolute Dentin® Core Composite by Parkell Dental

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (2)

  • FDA 510(k) K132115 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026