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510(k) K121318

PROSOFT by Perma Laboratories — Product Code EBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2012
Date Received
May 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Reliner, Denture, Over The Counter
Device Class
Class II
Regulation Number
872.3560
Review Panel
DE
Submission Type

Other clearances for product code EBP

  • K101771 — RELINE-IT MODEL RELINE-IT (September 20, 2010)
  • K790589 — DENTURE-TIGHT (August 10, 1979)