Biocompatibility: USP Class VI and ISO 10993-1 Information | Materials

Biocompatibility Information for Materials

A number of our plastic materials are ISO-10993 or USP Class VI capable. A selection of Figure 4, VisiJet, Accura and DuraForm plastic materials have met the requirements of ISO 10993-5, -10 or USP Class VI testing.

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 materials that are ISO 10993 or USP Class VI capable, and the applicable 3D printers.

Click on the material name below for available biocompatibility specification information and cleaning guide if applicable.

Material	Documents	Compatible Systems
Figure 4 RUBBER-65A BLK	Figure 4 RUBBER-65A BLK 20C0451H-X04.pdf, Post Processing information	Figure 4
Figure 4 MED-WHT 10	Figure 4 MED-WHT 10 ISO 10993-5 and -10 Summary Statement, Post Processing information	Figure 4
Figure 4 MED-AMB 10	Figure 4 MED-AMB 10 ISO 10993-5 and -10 Summary Statement, Post Processing information	Figure 4
Figure 4 Rubber-BLK 10	Figure 4 Rubber-BLK 10 ISO 10993-5 and -10 Summary Statement, Post Processing information	Figure 4
Figure 4 PRO-BLK 10	Figure 4 PRO-BLK 10 ISO 10993-5 and -10 Summary Statement, Post Processing information	Figure 4
Figure 4 Rigid White	Post Processing information	Figure 4
Figure 4 Tough 60C	Post Processing information	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
Accura ClearVue	USP Class VI Cert \| USP Class VI Letter \| Post Processing	SLA Systems
VisiJet M2E-BK70	USP Class VI Cert \| Post Processing	ProJet MJP 2500
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	M2R-WT ISO 10993 V1.1.pdf \| M2R-WT USP Class VI V1.1.pdf \| 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 M2S-HT250	USP Class VI Cert \| Post Processing	ProJet MJP 2500
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 on datasheet found here	SLS Printers

DISCLAIMER: It is the responsibility of each customer to determine that its use of any USP Class VI or ISO 10993 certified 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.