# K080305: Nexcomp and Meta Etchant

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Apr 7, 2008 after 62 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: 4 generations back to K863092 (1986). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070583: Nano Composite, Cosmedent, Inc. (2007) Summary page 1.
- K052097: Ceram X Universal Mano-Ceramic Restorative, Dentsply International (2005) Summary page 2.
- K003361: Renew LS-2, Bisco, Inc. (2000) Summary page 2.
- K982729: RENEW, Bisco, Inc. (1998) Summary page 2.
- K062409: K-Etchant Gel, Kuraray Medical, Inc. (2006) Summary page 3.
- K022492: Pulpdent Semi-Gel Etch, Pulpdent Corporation (2002) Summary page 3.

## Most influential descendants
- K181689: Nexcomp (2018), 0 descendants of its own

## Indications for use
Meta Etchant is intended for use in dentin/enamel etching to prepare the tooth surface for application of a bonding agent. Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class 1,11, 111, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.

Source page: https://510kreport.com/device/K080305
Methodology: https://510kreport.com/methodology