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Dentallabnetwork.com
Business Ideas
I'm DDS that wants to start a niche lab and I need help.
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<blockquote data-quote="prosthotech" data-source="post: 345665" data-attributes="member: 5409"><p>Depends on your state, county, and city. Most states don't require anything unless you are organizing a corp, LLC or dba. You will have to use a plaster trap, have adequate ventilation and air quality, and have an infection control and exposure protocols in place for incoming cases. If you have driver, you will have to have proper liability coverage for them and the vehicle. FDA only if you are producing whole implant abutments including prosthetic interface, for sleep apnea appliances, and imported work. However, as a licensed dentist, you may fall under exemptions for FDA registration. I'm sure there are ramifications to non-registration, so as with all legal matters, you should consult with a local attorney regarding questions of the law.</p><p></p><p>FDA registration is relatively expensive (depending on the size of your lab),will require additional paperwork and other office time, and opens up your premises to inspection authority from yet another state or federal agency. Most labs do not make whole custom abutments, and instead use pre-milled blanks, which have the prosthetic connection already made on a heavier mill. By the way, custom abutment made or modified by hand don't require FDA registration.</p></blockquote><p></p>
[QUOTE="prosthotech, post: 345665, member: 5409"] Depends on your state, county, and city. Most states don't require anything unless you are organizing a corp, LLC or dba. You will have to use a plaster trap, have adequate ventilation and air quality, and have an infection control and exposure protocols in place for incoming cases. If you have driver, you will have to have proper liability coverage for them and the vehicle. FDA only if you are producing whole implant abutments including prosthetic interface, for sleep apnea appliances, and imported work. However, as a licensed dentist, you may fall under exemptions for FDA registration. I'm sure there are ramifications to non-registration, so as with all legal matters, you should consult with a local attorney regarding questions of the law. FDA registration is relatively expensive (depending on the size of your lab),will require additional paperwork and other office time, and opens up your premises to inspection authority from yet another state or federal agency. Most labs do not make whole custom abutments, and instead use pre-milled blanks, which have the prosthetic connection already made on a heavier mill. By the way, custom abutment made or modified by hand don't require FDA registration. [/QUOTE]
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