Nexcomp and Meta Etchant

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Meta Etchant

Generic Name

Dental tooth-etching solution

Device Name

37% Phosphoric Acid Etching Gel

Model / Reference

Meta Etchant EUDAMED

Meta Etchant 5 EUDAMED

9209 GUDID

Primary DI / UDI-DI

08806387892090, 08806387892861

Basic UDI-DI

B-08806387892090, B-08806387892861

510(k) Number

K080305 ↗

FDA Product Code

EBF

EMDN Code

Q01010402 Enamel-dentinal etching materials

GMDN Term

Dental tooth-etching solution

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3690

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• M+W Gutta Percha Points

  Class IIa

  CE/MDD

• Dentac Gutta Percha Points

  Class IIa

  CE/MDD

• tgpaper points

  Class IIa

  CE/MDD

• Mega Absorbent Paper Points

  Class IIa

  CE/MDD

• Metapaste

  Class IIa

  CE/MDD

• Becht Paper Points

  Class IIa

  CE/MDD

See all devices from Meta Biomed Co., Ltd. →

• What is the Nexcomp and Meta Etchant system used for in dentistry and how does it differ from standard acid etchant applications?

  The Nexcomp and Meta Etchant system is designed for preparing tooth surfaces for bonding during cavity restorations and structural repairs. The Meta Etchant, containing 37% phosphoric acid in a polymer-thickened gel, creates micro-retentions on enamel and dentin, improving adhesion for the Nexcomp composite. Unlike traditional liquid etchants, its thixotropic gel formulation ensures easy application, complete rinsability, and minimizes overspray—ideal for precise dental work.

• Is the Meta Etchant reusable, and if not, why is it packaged as a single-use item?

  The Meta Etchant is explicitly intended for single-use due to its thixotropic gel formulation, which maintains consistency and sterility for one application. While the gel itself could theoretically be reused, the manufacturer specifies single-use to prevent contamination risks, ensure optimal performance, and comply with dental hygiene protocols for patient safety.

• How is the Nexcomp composite supplied, and what makes its filler composition unique compared to other dental composites?

  Nexcomp is supplied in refill tubes designed for screw-syringe application, allowing precise dispensing during restorative procedures. Its ultra-fine filler composition (75 wt.% filled) and radiopacity distinguish it from standard composites, providing enhanced mechanical strength, durability, and visibility under X-ray imaging for better diagnostic accuracy during follow-ups.

• What storage requirements should I follow for the Nexcomp and Meta Etchant kit to maintain its effectiveness?

  The kit should be stored in a cool, dry place away from direct sunlight and extreme temperatures. The Meta Etchant’s polymer-thickened gel formulation is sensitive to environmental conditions, so proper storage ensures its viscosity and acidity remain stable for optimal etching performance. Always check the expiration date on the packaging, as phosphoric acid-based products can degrade over time.

• How do I know if this system is compliant with international dental regulations, and what does the FDA 510(k) clearance mean for its use?

  The system holds FDA 510(k) clearance (K080305) under the Medical Device Directive (MDD) in Europe, confirming it meets U.S. and EU regulatory standards for dental etchants and composites. The clearance indicates the device is deemed *substantially equivalent* to a legally marketed predicate, meaning it shares the same intended use (tooth surface preparation and restoration) and technological characteristics. This does not imply approval for specific clinical outcomes but confirms compliance with safety and performance requirements.