Disclaimers

non dental usage disclaimer db 4000 is intended only for the fda cleared labeling indication described in its labeling and instructions for use the production of dental devices for fully edentulous patients db 4000 has not been validated for non dental applications or for dental applications outside the cleared indication for use all material property, mechanical, biocompatibility, orientation, support strategy, print setting, washing and curing validations were performed using the specified base geometries on a standard cassette, with manual washing and the dentsply digital cure large capacity curing device use of db 4000 outside the cleared indication for use, or outside the validated printing, washing and curing workflow, has not been evaluated by the manufacturer and is not covered by the fda cleared labeling such use may result in a device with unvalidated safety, performance, fit, durability or biocompatibility characteristics, and the user assumes responsibility for determining whether any such use complies with applicable regulatory requirements contact carbon mailto\ support\@carbon3d com for more information