ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

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.

Trade Name

Therapon Transpa

Prime

Model / Reference

TMASxx(x)yy(ww)(zzz(z)), TMIFxx(x)yy(ww)(zzz(z)), TMICxx(x)yy(ww)(zzz(z))

Primary DI / UDI-DI

D800TMASxx(x)yy(ww)(zzz(z))0, D800TMIFxx(x)yy(ww)(zzz(z))0, D800TMICxx(x)yy(ww)(zzz(z))0

Basic UDI-DI

++D800RES010001HF, ++D800RES002001HJ

Direct Marketing DI

D800TMIFxx(x)yy(ww)(zzz(z))0

D800TMICxx(x)yy(ww)(zzz(z))0

510(k) Number

K200676 ↗

FDA Product Code

EBG

EMDN Code

Q01020605 Temporary dental prostheses

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 872.3770

EU market of registration

Italy

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Colour Liquid A1 (20 ml) FMAA0103

  Class II

  GUDID on market

• Colour Liquid A3, 5 (20 ml) FMAA0403

  Class II

  GUDID on market

• Colour Liquid B1 (20 ml) FMAA0603

  Class II

  GUDID on market

• Colour Liquid A4 (20 ml) FMAA0503

  Class II

  GUDID on market

• Colour Liquid B2 (20 ml) FMAA0703

  Class II

  GUDID on market

• Colour Liquid B3 (20 ml) FMAA0803

  Class II

  GUDID on market

See all devices from Zirkonzahn GmbH →

• Are these materials intended for direct patient application in a clinical setting, or are they meant for fabrication in a dental lab first?

  These materials are designed for professional use in dental laboratories or clinics to fabricate dental prosthetics and appliances. ABRO 1 is used for creating denture teeth, Resiton Gingiva for denture bases, and Prime/Therapon Transpa for bite splints, orthodontic splints, and occlusal splints. They are not sterile at time of supply and must be processed according to standard dental fabrication protocols before patient use.

• How should these dental resins be stored, and are there any special handling instructions?

  Storage and handling of these materials follow general guidelines for dental resins. Since they are not sterile at time of supply, they should be stored in a clean, dry environment, away from direct sunlight and extreme temperatures, to maintain their integrity. Always refer to the manufacturer’s instructions for precise storage conditions and ensure they are kept out of reach of unauthorized personnel.

• Can these materials be reused after fabrication, or are they intended for single-use only?

  These dental resins are intended for fabrication into dental prosthetics and appliances, which are typically single-use or designed for long-term patient use depending on the application. The materials themselves are not reusable—they are processed into custom devices like denture teeth, bases, or splints, which are patient-specific and not meant for reuse.

• What types of dental appliances can Prime and Therapon Transpa be used to create, and how do they differ from ABRO 1 and Resiton Gingiva?

  Prime and Therapon Transpa are specialized resins specifically formulated for fabricating bite splints, orthodontic splints, and occlusal splints to manage conditions like bruxism. In contrast, ABRO 1 is used exclusively for fabricating denture teeth, while Resiton Gingiva is designed for creating denture bases. These distinctions allow each material to meet the unique requirements of its intended application.

• What regulatory pathways have these materials gone through, and what does that mean for their use in clinical settings?

  These materials have undergone FDA 510(k) clearance (K200676) under the Traditional pathway and are classified as Class II devices, indicating they have been reviewed for substantial equivalence to a predicate device. They are also compliant with the EU Medical Device Regulation (MDR). This means they meet established safety and performance standards for dental resins used in crown and bridge, temporary resin applications, and are restricted to use by qualified dental professionals.