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510(k) K181965

Restore Toothpaste by Dr. Collins, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2019
Date Received
July 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

Other clearances by Dr. Collins, Inc.

  • K200077 — BioMin Restore Plus (November 6, 2020)

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  • K242913 — Jasmate® Toothpaste (November 22, 2024)
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  • K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal (July 24, 2023)
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