# K132115: Absolute Dentin 2

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Jun 25, 2014 after 351 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984097 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010475: D/C Core Material, Parkell, Inc. (2001) Summary page 1.
- K000211: Build-IT FR, Jeneric/Pentron, Inc. (2000) Summary page 1.
- K984097: DC-Core, S & C Polymer GmbH (1999) Summary page 1.

## Indications for use
A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.

Source page: https://510kreport.com/device/K132115
Methodology: https://510kreport.com/methodology