Opal Seal

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

Dental pit/fissure sealant

Model / Ref / Catalog

500062

Primary DI / UDI-DI

00883205103277

Basic UDI-DI

0883205-TF286BR

510(k) Number

K090355 ↗

FDA Product Code

DYH

EMDN Code

Q01010104 Dental bonding agents

GMDN Term

Dental pit/fissure sealant

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3750

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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• What is the Opal Seal used for in a dental setting and how does it prepare tooth surfaces?

  The Opal Seal is an adhesive resin designed specifically to condition tooth enamel before bonding orthodontic brackets or restorative materials. It creates a durable bonding interface by preparing the tooth surface, ensuring proper adhesion for long-lasting results in orthodontic treatments or dental restorations.

• Is the Opal Seal intended for single-use or can it be reused?

  The Opal Seal is explicitly supplied as a single-use resin adhesive. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and bonding effectiveness.

• What regulatory pathways does the Opal Seal follow in the U.S. and EU?

  In the U.S., the Opal Seal is cleared through the FDA 510K process (K090355) under the Dental (DE) Advisory Committee, classified as a Class II device. It also complies with the EU Medical Device Regulation (MDR). Both pathways confirm its suitability for conditioning enamel and bonding applications.

• How many registration numbers are associated with the Opal Seal, and why might this matter?

  The Opal Seal has multiple registration numbers (e.g., 1815540, 3008882689, etc.), totaling over 50 listed in the data. These identifiers are used for tracking, compliance, and inventory management in regulatory databases, ensuring traceability across different markets or distribution channels.

• Does the Opal Seal require special handling to maintain sterility, and what are the storage considerations?

  While the data does not specify exact storage conditions or shelf life, the Opal Seal is described as requiring proper handling to maintain sterility due to its single-use nature. Clinicians should follow manufacturer guidelines (available in accompanying documentation) to preserve its integrity before use.