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510(k) K051342

MEDICAL INTERPOROUS by Bonyf AG — Product Code EFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2006
Date Received
May 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Denture, Over The Counter
Device Class
Class I
Regulation Number
872.3520
Review Panel
DE
Submission Type

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  • K942203 — OTC DENTURE CLEANSER (August 10, 1994)
  • K930337 — PROFAST(R)-DENTURE CLEANSER (September 7, 1993)
  • K914257 — DENTURE PRODUCT X (January 13, 1993)
  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K902838 — DENTURE DYNAMIC'S DENTURE MAGIC (September 6, 1990)
  • K903686 — ARGILITE 4 GOLD ALLOY FOR PORCELAIN (August 29, 1990)
  • K895345 — ORAD TOOTHBRUSH CLEANER (March 7, 1990)
  • K890043 — DENTCLEAN CONCENTRATED DENTURE CLEANSER (June 7, 1989)