FDA 510(k) Application Details - K232429

Device Classification Name

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510(K) Number K232429
Device Name Titan Dental Design
Applicant ClearAdvance, LLC
18 Endeavor, STE 107
Irvine, CA 92618 US
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Contact Frank Puig
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Regulation Number

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Classification Product Code PNN
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Date Received 08/11/2023
Decision Date 10/13/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K232429


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