Statement of Conformity

This statement is being supplied with a custom-made medical device in accordance with subclause 7.2(3A) of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). This custom-made medical device was manufactured by DigiDent (DD). The device is a specified overleaf that can be identified by the following features-  A prosthetic device constructed to artificially replace edentulous areas, with patient matched skin coloured base and custom colour selected teeth, designed to be supported by the surrounding soft and hard tissues of the oral cavity. The device[s] is custom-made for the patient overleaf and intended only to be used in relation to that individual, according to specifications provided by the issuing clinician. The following design and/or construction characteristics of the device when is was requested to be manufactured: 

Specifications: Transitional—Tooth material:CROWNTEC for NextDent, NextDent C&B MFH (Micro Filled Hybrid), Rodin® Sculpture 2.0, (Apex Teeth), Base material: NextDent Base, NextDent Denture 3D+, Rodin® Denture Base 2.0, (Apex Base), Arcylic Teeth (

Specifications: Hybrid - OnX Tough 2, Rodin® Titan

Specifications: Try-in—NextDent Try-In, Rodin™ Try-In , SprintRay Try-In 2

Specifications: Final—Tooth material:VITA VIONIC D-Set, VITA VIONIC MULTI, Kryptonite Digital Denture, Base material: VITA VIONIC BASE II HI, VITA VIONIC BASE, Zirkon Zahn DENTURE GINGIVA, Bonding agent: VITA VIONIC Bond, VITA VIONIC Bond II, Zirkon Zahn Polibond, Customisation: VITA AKZENT® LC, Pala CreActive, GC Optiglaze, Zirkon Zahn Composite Paste Tissue, Zirkon Zahn Composite Fluid Tissue, Rodin™ Palette

Specifications: Acrylic Full/Partial: Framework-CoCr/Vitallium,Solvay Ultaire,PEEK,PEKK, TCS, Acetal, Teeth-Acrylic. Denture teeth- VITA,Delara,Acrylux or as per lab/tech. Denture acrylic—PalaXtreme, PalaXpress,Diamond D, Paladon (or as per lab/tech)

DigiDent certifies that the device complies with the applicable provisions of the Essential Principles of Schedule 1 of the Regulations. This statement will be kept on file by PMD for 5 years, in accordance with subclause 7.6(2) of Schedule 3 of the Regulations. This statement was compiled by Jason Petley Dental Prosthetist (BDPros, BIT, LAP) Reg. DEN0002319405 on the date overleaf,  in accordance with the requirements of subclause 7.2(2) of Schedule 3 the Regulations.