# K984387: R-30 Aesthetic Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jan 13, 1999 after 36 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: 2 generations back to K863092 (1986). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973221: Composite 168 Restorative System, Dentsply Intl. (1998) Summary page 1.

## Most influential descendants
- K052097: Ceram X Universal Mano-Ceramic Restorative (2005), 2 descendants of its own
- K080305: Nexcomp and Meta Etchant (2008), 1 descendant of its own
- K181689: Nexcomp (2018), 0 descendants of its own

## Indications for use
R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlays and onlays.

Source page: https://510kreport.com/device/K984387
Methodology: https://510kreport.com/methodology