Biocompatibility: USP Class VI and ISO 10993-1 Information

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 StatementPost Processing information Figure 4

Figure 4 MED-AMB 10

Figure 4 MED-AMB 10 ISO 10993-5 and -10 Summary StatementPost Processing information Figure 4

Figure 4 Rubber-BLK 10

Figure 4 Rubber-BLK 10 ISO 10993-5 and -10 Summary StatementPost Processing information Figure 4

Figure 4 PRO-BLK 10

Figure 4 PRO-BLK 10 ISO 10993-5 and -10 Summary StatementPost 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 Sheet 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.