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Biocompatibility: USP Class VI and ISO 10993-1 Information

USP Class VI and ISO 10993-1 Certification for Materials

A number of our plastic materials are now USP Class VI Capable.
A selection of VisiJet, Accura and DuraForm plastic materials have met the requirements of USP Class VI* certification testing. These materials are now suitable for approved applications in the medical industries.
The materials listed below are ideal for:

3D printing of dental and orthopedic surgical guides

3D printing of one day crown prep guides.

Use of parts in other medical applications

The following table lists the material that are USP Class VI capable and the applicable 3D Printers:

Click on the material name below for the USP Class VI certification letter and cleaning guide

Material Documents Compatible Systems
Figure 4 MED-WHT 10 19D0184H-X05 Summary Statement Figure 4
Figure 4 MED-AMB 10 19D0183H-X05 Summary Statement Figure 4 
Figure 4 Rubber-BLK 10 19J0056H-X04 Summary Statement Figure 4
Figure 4 PRO-BLK 10 19J0056H-X04 Summary Statement Figure 4

VisiJet M3 Crystal

(EX 200)

USP Class VI Cert, Letter and Post Processing 

USP Class VI Cert, Letter and Post Processing

 ProJet 3510 SD, 3510 HD, 3510HDPlus, 3500 HDMax, 3600W, 3600W Max

VisiJet M3 Stoneplast

(MP 200)

USP Class VI Cert, Letter and Post Processing

USP Class VI Cert, Letter and Post Processing

 ProJet 35XX, 3600, MP and DP Pro
VisiJet SL Clear 

VisiJet Clear Plastic Material 

USP Class VI Cert | USP Class VI Letter Nov 2015 | Post Processing

 ProJet 6000, ProJet 7000
Accure ClearVue

USP Class VI Cert | USP Class VI Letter | Post Processing

 SLA Systems

VisiJet M2R - CL

With Clear Coat

USP Class VI Cert | USP Class VI Letter | ISO 10993 | Post Processing

wCC ISO 10993 | Post Processing

 ProJet MJP 2500
VisiJet M2R - GRY USP Class VI Cert | USP Class VI Letter | Post Processing ProJet MJP 2500
VisiJet M2R - TN USP Class VI Cert | USP Class VI Letter | Post Processing ProJet MJP 2500
VisiJet M2R - WT USP Class VI Cert | USP Class VI Letter | ISO 10993 | Post Processing ProJet MJP 2500
Visijet M2S-HT90 M2S-HT90 USP Class VI V1.1.pdf | M2S-HT90 Class VI Certificate.pdf | Post Processing ProJet MJP 2500 Plus
VisiJet CR - BK USP Class VI Cert | USP Class VI Letter | Post Processing ProJet MJP 5600
VisiJet CR - CL 200 USP Class VI Cert | USP Class VI Letter | Post Processing ProJet MJP 5600
VisiJet CR - WT 200 USP Class VI Cert | USP Class VI Letter | Post Processing ProJet MJP 5600
DuraForm PA USP Class VI Cert | Regulatory Information Sheet  SLS Printers
DuraForm ProX PA Regulatory Information Sheet SLS Printers

 

DISCLAIMER: It is the responsibility of each customer to determine that its use of any USP Class VI certified VisiJet® material is safe, lawful and technically suitable to the customer’s intended applications. Customers should conduct their own testing to ensure that this is the case.