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510(k) K022032

ACETAL by Inovativ, LLC — Product Code EHP

K022032 is an FDA 510(k) premarket notification submitted by Inovativ, LLC for the device "ACETAL". The FDA issued a decision of Substantially Equivalent on August 29, 2002. The device falls under product code EHP (Clasp, Preformed), a Class I device regulated under 21 CFR 872.3285. Inovativ, LLC has at least 2 other 510(k) clearances on record.

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

FDA data resources