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FDA 510(k) Application Details - K221761
Device Classification Name
Laser, Dental, Soft Tissue
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
NVK
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More FDA Info for this Product Code
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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