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510(k) K935153

DENTAURUM BRACKET POSITIONING GAUGE by Dentauraum, Inc. — Product Code ECQ

K935153 is an FDA 510(k) premarket notification submitted by Dentauraum, Inc. for the device "DENTAURUM BRACKET POSITIONING GAUGE". The FDA issued a decision of Substantially Equivalent on January 31, 1994. The device falls under product code ECQ (Aligner, Bracket, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Dentauraum, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1994
Date Received
October 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aligner, Bracket, Orthodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Dentauraum, Inc.

  • K952870 — REMANIUM: CS & G-SOFT (July 27, 1995)
  • K952866 — REMATITAN TITANIUM (July 27, 1995)
  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952865 — REMANIUM: 200,CS, 380, AND CD (July 26, 1995)
  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K942666 — ORTHALGENAT IMPRESSION MATERIAL (August 10, 1994)
  • K936151 — EXTRAORAL HEADGEAR (August 1, 1994)
  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)
  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)

Other clearances for product code ECQ

  • K851454 — A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS (April 29, 1985)

FDA data resources