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510(k) K954971

ACETAL DENTAL/PREFORMED CLASP by B & H Technical Services , Ltd. — Product Code EHP

K954971 is an FDA 510(k) premarket notification submitted by B & H Technical Services , Ltd. for the device "ACETAL DENTAL/PREFORMED CLASP". The FDA issued a decision of Substantially Equivalent on December 11, 1995. The device falls under product code EHP (Clasp, Preformed), a Class I device regulated under 21 CFR 872.3285.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1995
Date Received
October 27, 1995
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 for product code EHP

  • K022032 — ACETAL (August 29, 2002)
  • K983558 — ACETAL DENTAL/PREFORMED CLASP (January 7, 1999)
  • K974622 — DENTAL D (February 10, 1998)
  • K955946 — 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