UltraSeal XT Hydro

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 23 Oct 2026.

Trade Name

UltraSeal XT hydro EUDAMED

UltraSeal XT GUDID

Generic Name

Dental unfilled resin sealant/coating

Model / Ref / Catalog

3534, 3533, 3532, 3536

Primary DI / UDI-DI

00883205104175, 00883205104151, 00883205045010, 00883205045027, 00883205104182, 00883205104199

Basic UDI-DI

0883205-REF35326S, 0883205-TF018AW, 0883205-REF35336U

510(k) Number

K112517 ↗

FDA Product Code

EBC

EMDN Code

Q010199 Conservative dentistry and endodontics devices - other

GMDN Term

Dental unfilled resin sealant/coating

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3765

EU market of registration

Germany

Advisory Committee

Dental

Medical Purpose

Dental Sealant

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Opalescence Boost

  Class IIa

  CE/MDR

• ViscoStat Clear

  Class IIa

  CE/MDR

• Ultra-Etch

  Class IIa

  CE/MDR

• Ultrapro Tx S8303

  Class I

  GUDID on market

• Transcend 5876

  Class II

  GUDID on market

• Thermo Clone 6065

  Class I

  GUDID on market

See all devices from Ultradent Products, Inc. →

• What is UltraSeal XT Hydro primarily used for in dental practice?

  UltraSeal XT Hydro is designed to prevent dental caries by sealing the occlusal (chewing) surfaces of teeth, particularly in deep pits and fissures where bacteria can accumulate. Its adhesive technology helps create a strong bond to enamel, reducing the risk of decay in these vulnerable areas.

• Is UltraSeal XT Hydro single-use or reusable, and what does that mean for my practice?

  UltraSeal XT Hydro is supplied as a single-use product, meaning each application requires a new syringe. This ensures sterility and consistency in performance, as reuse could compromise the material’s integrity or introduce contamination risks. Since it’s non-sterile, it’s intended for immediate use in a dental office setting.

• How is UltraSeal XT Hydro different from other sealants in terms of durability and wear resistance?

  UltraSeal XT Hydro features a 53% resin fill, which enhances its wear resistance compared to traditional sealants. This formulation also minimizes polymerization shrinkage, helping maintain a tighter seal over time. Its radiopacity and fluoride release further support long-term protection against caries.

• What storage conditions should I follow for UltraSeal XT Hydro to maintain its effectiveness?

  Since UltraSeal XT Hydro is non-sterile and single-use, it should be stored in a cool, dry place (typically 15–25°C/59–77°F) away from direct sunlight or extreme temperatures. Always check the expiration date on the packaging before use, as prolonged exposure to heat or light could degrade the material’s adhesive properties or fluoride release.

• What regulatory pathways does UltraSeal XT Hydro follow, and how does that affect its use in my country?

  UltraSeal XT Hydro is authorized under FDA 510K (K112517) in the U.S. and meets MDR (Medical Device Regulation) requirements in the EU. Its classification as a Class II device under FDA regulation 872.3765 indicates it undergoes stringent review for safety and effectiveness. For global use, verify local compliance—while it’s approved in these regions, additional registrations or certifications may be required elsewhere.