# K181689: Nexcomp

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Nov 15, 2018 after 142 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: 5 generations back to K863092 (1986). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080305: Nexcomp and Meta Etchant, Meta Biomed Co., Ltd. (2008) Summary page 4.

## Indications for use
Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class 1, II, Ill, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diasterna closure. direct veneers, composite and porcelain repairs.

Source page: https://510kreport.com/device/K181689
Methodology: https://510kreport.com/methodology