Home / 510(k) Clearances / K983558

510(k) K983558

ACETAL DENTAL/PREFORMED CLASP by Dentamax, Inc. — Product Code EHP

K983558 is an FDA 510(k) premarket notification submitted by Dentamax, Inc. for the device "ACETAL DENTAL/PREFORMED CLASP". The FDA issued a decision of Substantially Equivalent on January 7, 1999. The device falls under product code EHP (Clasp, Preformed), a Class I device regulated under 21 CFR 872.3285. Dentamax, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1999
Date Received
October 13, 1998
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 Dentamax, Inc.

  • K990448 — THE.R.MO.FREE (March 23, 1999)

Other clearances for product code EHP

  • K022032 — ACETAL (August 29, 2002)
  • 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