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510(k) K915653

KERAMAIL by Wilde-USA, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
December 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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  • K912990 — CONVERBASE (March 25, 1992)
  • K920557 — WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX (March 20, 1992)
  • K915654 — KERALLOY-D CAPS (March 2, 1992)
  • K912993 — WILDE DENTURE RESINS (February 3, 1992)

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