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510(k) K240743

Peak Universal Bond by Ultradent Products, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2024
Date Received
March 18, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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