Ketac Applic-Capsules

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790832 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Palgaflex and Palgaflex-Quick

  Class II

  FDA 510(k) K884381 Active Cleared 4 Jan 1989

• Permagum Adhesive

  Class II

  FDA 510(k) K771853 Active Cleared 13 Oct 1977

• Photac-Bond

  Class II

  FDA 510(k) K904096 Active Cleared 19 Nov 1990

• Rocatec(R) -Plus

  Class II

  FDA 510(k) K913857 Active Cleared 16 Dec 1991

• Visio-Perl

  Class II

  FDA 510(k) K882566 Active Cleared 19 Oct 1988

• Espe Ketac-Cem Radiopaque

  Class II

  FDA 510(k) K844846 Active Cleared 25 Mar 1985

See all devices from Espe GmbH (Us) →

• What is the Ketac Applic-Capsules used for in dental procedures?

  The Ketac Applic-Capsules are designed as Glass Ionomer Luting Cement for dental restorations. They chemically bond to enamel and dentin, providing a durable and radiopaque seal. This helps maintain marginal integrity while also releasing fluoride to support remineralization and reduce caries risk.

• How are the Ketac Applic-Capsules supplied and intended for use?

  These capsules are supplied individually for single-use, ensuring sterility is not required as they are non-sterile. They are packaged in quantities of 50 per pack, intended for clinical use in dental settings where proper handling is necessary before application.

• Are the Ketac Applic-Capsules reusable or single-use?

  The Ketac Applic-Capsules are explicitly designed for single-use only. Each capsule is intended to be used once and then discarded, which helps maintain hygiene and prevent cross-contamination in clinical environments.

• What regulatory approval does the Ketac Applic-Capsules hold?

  The Ketac Applic-Capsules are authorized by the FDA under 510(k) clearance with the reference number K790832. They fall under FDA device class 2 and are regulated under the regulation number 872.3275 for dental cements.

• How should the Ketac Applic-Capsules be stored?

  Since the capsules are non-sterile, they should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Proper packaging should remain intact until use to preserve their integrity and prevent contamination.