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510(k) K022030

POLY-CARB by Inovativ, LLC — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2002
Date Received
June 21, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

Other clearances by Inovativ, LLC

  • K024282 — ACRYLIC (March 21, 2003)
  • K022032 — ACETAL (August 29, 2002)

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