# K984037: Core-Ide

- Pathway: 510(k) (Traditional)
- Applicant: Roydent Dental Products, Inc.
- Decided: Feb 4, 1999 after 84 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BIS-CORE Core Build Up Composite: named in the summary without a submission number

## Indications for use
DC-Core / Core-Ide is a self cure micro hybride composite for endodontic post cementations and core build-ups (see enclosed Instruction for Use, MSDS).

Source page: https://510kreport.com/device/K984037
Methodology: https://510kreport.com/methodology