Adseal Root Canal Sealer

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

Adseal

Model / Reference

ADSEAL 4.5

Primary DI / UDI-DI

08806387893110

Basic UDI-DI

B-08806387893110

510(k) Number

K042769 ↗

FDA Product Code

KIF

EMDN Code

Q01010202 Root canal filling dental cements

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 872.3820

EU market of registration

France

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• M+W Gutta Percha Points

  Class IIa

  CE/MDD

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  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. →

• Is the Adseal Root Canal Sealer intended for reuse or is it single-use only?

  The Adseal Root Canal Sealer is explicitly supplied as a single-use material, meaning it is designed for one-time clinical application per package. Reuse is not recommended or supported by the manufacturer to ensure sterility and performance integrity.

• How should the Adseal Root Canal Sealer be stored before use?

  While the device data does not specify exact storage conditions, the manufacturer’s guidelines (referenced in the description) must be followed to maintain product integrity. Generally, resin-based materials like this should be stored in a cool, dry place away from direct sunlight and extreme temperatures, as per standard dental material handling practices.

• What regulatory pathways has the Adseal Root Canal Sealer followed for approval?

  The Adseal Root Canal Sealer has undergone FDA 510K clearance and complies with the Medical Device Directive (MDD) in the EU. It is classified as a Class II device under FDA regulations, indicating it has undergone substantial equivalence reviews by the Dental Devices Expert Panel (DE).

• Is the Adseal Root Canal Sealer sterile when supplied, or does it require additional sterilization?

  The device is supplied as non-sterile, meaning it is not pre-sterilized and must be handled in a clinical setting where standard aseptic techniques are applied prior to use. Sterilization procedures should align with the manufacturer’s instructions to ensure safety and efficacy.

• What are the key differences between the Adseal Root Canal Sealer and other resin-based root canal filling materials?

  The Adseal Root Canal Sealer is specifically designed to seal the root canal system during endodontic therapy, preventing microbial leakage and ensuring a hermetic seal. Unlike some alternatives, it is single-use and resin-based, which may influence handling, setting time, and biocompatibility. For precise comparisons, consult clinical studies or manufacturer data sheets, as the device data does not detail competitive specifications.