Permaseal

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 unfilled resin sealant/coating

Model / Ref / Catalog

1013

Primary DI / UDI-DI

00883205104045

Basic UDI-DI

0883205-TF271PermaER

510(k) Number

K950859 ↗

FDA Product Code

EBF

EMDN Code

Q01010103 Dental restorative composites

GMDN Term

Dental unfilled resin sealant/coating

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

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• What types of dental restorations can the Permaseal adhesive be used with, and how does it improve the bond between the restoration and tooth structure?

  The Permaseal adhesive is specifically designed for bonding and sealing restorative materials such as dental fillings, crowns, or other dental restorations to the underlying tooth structure. It creates a durable interface, ensuring a strong and long-lasting bond that helps prevent microleakage, which can lead to secondary decay or sensitivity. This makes it suitable for a wide range of clinical applications where a reliable seal is critical.

• Is the Permaseal adhesive single-use, and if so, why is this important for clinical settings?

  Yes, the Permaseal adhesive is supplied as a single-use system, meaning each application requires a new unit. This design ensures sterility and hygiene in clinical settings, as it eliminates the risk of cross-contamination between patients. Single-use also simplifies inventory management and reduces the need for sterilization or cleaning procedures, which can be time-consuming and potentially introduce errors.

• What storage conditions should be followed for the Permaseal adhesive, and why aren’t specific storage instructions provided in the device data?

  While the device data does not specify exact storage conditions, it is generally recommended to follow standard protocols for dental adhesives, such as storing in a cool, dry place away from direct sunlight and extreme temperatures. The omission of detailed storage instructions likely means these are industry-wide best practices rather than unique requirements for this product. Adhering to these guidelines helps maintain the adhesive’s efficacy and shelf life.

• How is the Permaseal adhesive authorized for use, and what does this mean for clinicians or dental practices?

  The Permaseal adhesive holds both FDA 510(k) clearance (K950859) and MDR compliance, indicating it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed predicate device. For clinicians, this means the product has been evaluated for safety and effectiveness according to established standards, providing confidence in its performance for bonding and sealing dental restorations. The authorization also ensures it meets the necessary quality and performance criteria for clinical use.