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510(k) K942667

DENT-O-CRYL ORTHODONTIC ACRYLIC by Dentauraum, Inc. — Product Code KMY

K942667 is an FDA 510(k) premarket notification submitted by Dentauraum, Inc. for the device "DENT-O-CRYL ORTHODONTIC ACRYLIC". The FDA issued a decision of Substantially Equivalent on February 13, 1995. The device falls under product code KMY (Positioner, Tooth, Preformed), a Class I device regulated under 21 CFR 872.5525. Dentauraum, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1995
Date Received
June 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Positioner, Tooth, Preformed
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type

Other clearances by Dentauraum, Inc.

  • K952870 — REMANIUM: CS & G-SOFT (July 27, 1995)
  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952866 — REMATITAN TITANIUM (July 27, 1995)
  • K952865 — REMANIUM: 200,CS, 380, AND CD (July 26, 1995)
  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K942666 — ORTHALGENAT IMPRESSION MATERIAL (August 10, 1994)
  • K936151 — EXTRAORAL HEADGEAR (August 1, 1994)
  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)
  • K935856 — DENTAURUM SPACE MAINTAINER (April 28, 1994)

Other clearances for product code KMY

  • K931615 — NITE-GUIDE (April 14, 1995)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • K925064 — RELAX-O-GUARD (September 13, 1993)
  • K924975 — THE ORTHOTRAINER (July 8, 1993)
  • K924974 — THE TMJ APPLIANCE (June 23, 1993)
  • K904128 — PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER (November 9, 1990)
  • K891328 — PREFORMED TEMPLATE FOR TOOTH POSITIONER (March 31, 1989)
  • K833455 — REMOLDABLE CRANIOMANDIBULAR APPLIANCE (January 10, 1984)
  • K831793 — AQUALIZER MOUTHPIECE (August 12, 1983)
  • K821458 — DYNAMIC FUNTIONAL POSITIONER (June 9, 1982)

FDA data resources