Home / 510(k) Clearances / K022032

510(k) K022032

ACETAL by Inovativ, LLC — Product Code EHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2002
Date Received
June 21, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clasp, Preformed
Device Class
Class I
Regulation Number
872.3285
Review Panel
DE
Submission Type

Other clearances by Inovativ, LLC

  • K024282 — ACRYLIC (March 21, 2003)
  • K022030 — POLY-CARB (August 28, 2002)

Other clearances for product code EHP

  • K983558 — ACETAL DENTAL/PREFORMED CLASP (January 7, 1999)
  • K974622 — DENTAL D (February 10, 1998)
  • K954971 — ACETAL DENTAL/PREFORMED CLASP (December 11, 1995)
  • K955946 — ACETAL DENTAL/PREFORMED CLASP (December 11, 1995)
  • K854765 — INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH (June 13, 1986)
  • K800574 — VACUDENT LUMIX 65 (May 20, 1980)
  • K800575 — VACUDENT LUMIX 70 (May 20, 1980)