FDA 510(k) Application Details - K221761

Device Classification Name Laser, Dental, Soft Tissue

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510(K) Number K221761
Device Name Laser, Dental, Soft Tissue
Applicant Convergent Dental, Inc.
140 Kendrick Street
Needham, MA 02494 US
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Contact Jhung Vojir
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Regulation Number 878.4810

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Classification Product Code NVK
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Date Received 06/17/2022
Decision Date 09/14/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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