UltraCal XS Resin Root Canal Filling

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.

Full name

UltraCal XS

Generic Name

Calcium hydroxide dental suspension

Model / Ref / Catalog

5144

Primary DI / UDI-DI

00883205033246

Basic UDI-DI

0883205-TF017AU

510(k) Number

K970114 ↗ 510(k)

K211905 ↗ GUDID

FDA Product Code

EJK 510(k)

KIF GUDID

EMDN Code

Q01010201 Root canal filling dental pastes

GMDN Term

Calcium hydroxide dental suspension

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 872.3250 510(k)

872.3820 GUDID

EU market of registration

Germany

Advisory Committee

Dental

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 the UltraCal XS Resin Root Canal Filling used for in clinical practice?

  The UltraCal XS is a resin-based material specifically designed for sealing the root canal system during root canal therapy. After the root canal space is mechanically prepared, this device provides a biocompatible and durable restoration to help prevent bacterial leakage and maintain the integrity of the treated tooth.

• Is the UltraCal XS single-use or reusable, and how is it packaged?

  The UltraCal XS is supplied as a single-use, sterile material, meaning each package is intended for one clinical procedure. This ensures sterility and performance consistency, as it is not meant for reuse.

• What regulatory pathways does the UltraCal XS follow in the U.S. and Europe?

  In the U.S., the UltraCal XS has received FDA clearance through a 510(k) submission (K211905), classified as substantially equivalent under traditional review by the Dental Devices Advisory Committee. In Europe, it complies with the EU Medical Device Regulation (MDR).

• How should the UltraCal XS be stored to maintain its integrity?

  The UltraCal XS must be stored according to manufacturer guidelines to preserve sterility and performance. Since it is single-use and sterile, it should remain in its original packaging until immediately before use, protected from contamination and extreme environmental conditions.

• Are there any specific size or model variations available for the UltraCal XS?

  The provided data does not specify individual size or model variations for the UltraCal XS. However, it is classified as a resin root canal filling, so typical variations may include different tip sizes or tip shapes to accommodate various root canal anatomies. For precise sizing details, refer to the manufacturer’s product catalog or technical documentation.