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510(k) K260682

Bond-PR™ Universal Adhesive by Premier Dental Products Company — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2026
Date Received
March 2, 2026
Clearance Type
Traditional
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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