Visio-Perl

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K882566 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• 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

• Espe Ketac-Cem Radiopaque

  Class II

  FDA 510(k) K844846 Active Cleared 25 Mar 1985

• Espetemp (Temp. Cement)

  Class II

  FDA 510(k) K770923 Active Cleared 1 Jun 1977

See all devices from Espe GmbH (Us) →

• What is the Visio-Perl used for in dental procedures and how does it help achieve natural-looking results?

  The Visio-Perl is a tooth shade resin specifically designed for dental restorative procedures to provide precise color matching. It ensures that dental restorations blend seamlessly with natural teeth, enhancing aesthetic integration and patient satisfaction.

• Is the Visio-Perl intended for single-use or can it be reused after sterilization?

  The Visio-Perl is explicitly supplied as a single-use material. Since it is not designed for reuse or sterilization, dental offices should adhere to standard protocols for single-use dental materials to maintain hygiene and safety.

• How is the Visio-Perl regulated in the U.S., and what classification does it fall under?

  The Visio-Perl is regulated under the FDA’s 510(k) clearance process and is classified as a Class II device under Special Controls. It was granted clearance under the product code EBF (Dental Materials) and is intended for use in dental offices following standard hygiene practices.

• Does the Visio-Perl require any special handling or storage conditions?

  While the provided data does not specify unique storage conditions, as a dental restorative material, the Visio-Perl should be stored according to standard dental material protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity.