Meta P&Bond

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.

Generic Name

Dentine bonding agent/set

Device Name

Light Cured Dental Adhesive

Model / Reference

Meta P&Bond EUDAMED

9410 GUDID

Primary DI / UDI-DI

08806387894100

Basic UDI-DI

B-08806387894100

510(k) Number

K180802 ↗

FDA Product Code

KLE

EMDN Code

Q01010104 Dental bonding agents

GMDN Term

Dentine bonding agent/set

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3200

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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

• What is the primary purpose of the Meta P&Bond dental agent, and how does it function in a clinical setting?

  Meta P&Bond is a Tooth Bonding Resin designed specifically to bond dental restorations—such as fillings, crowns, or other prosthetics—to natural tooth structures. It works by chemically adhering to both enamel and composite resins, ensuring a durable and long-lasting bond that helps secure restorations in place. This is particularly useful in procedures where stability and longevity of the restoration are critical.

• Is the Meta P&Bond system single-use or reusable, and how should it be stored to maintain its effectiveness?

  The Meta P&Bond is supplied as a single-use resin system, meaning each package is intended for one application only. To preserve its efficacy, it must be stored according to the manufacturer’s instructions, which likely include protection from moisture, extreme temperatures, and direct light. Always check the packaging for specific storage guidelines.

• What regulatory pathways has the Meta P&Bond undergone, and what does this mean for its use in dental practices?

  The Meta P&Bond has received FDA 510K clearance and complies with the MDD (Medical Device Directive). This means it has been evaluated by regulatory authorities to demonstrate substantial equivalence to a predicate device and meets the necessary safety and performance standards for dental bonding resins. Clinicians can use it with confidence, knowing it adheres to established regulatory requirements.

• Is the Meta P&Bond system sterile or non-sterile, and what does this imply for its handling in a dental clinic?

  The Meta P&Bond is non-sterile as supplied, which means it does not require additional sterilization before use. However, standard dental clinic protocols for aseptic technique should still be followed to minimize contamination risks during application. The non-sterile classification aligns with its intended single-use nature in controlled clinical environments.