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510(k) K935856

DENTAURUM SPACE MAINTAINER by Dentauraum, Inc. — Product Code DYT

K935856 is an FDA 510(k) premarket notification submitted by Dentauraum, Inc. for the device "DENTAURUM SPACE MAINTAINER". The FDA issued a decision of Substantially Equivalent on April 28, 1994. The device falls under product code DYT (Maintainer, Space Preformed, Orthodontic), 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
April 28, 1994
Date Received
December 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Maintainer, Space Preformed, Orthodontic
Device Class
Class I
Regulation Number
872.5525
Review Panel
DE
Submission Type

Other clearances by Dentauraum, Inc.

  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952866 — REMATITAN TITANIUM (July 27, 1995)
  • K952870 — REMANIUM: CS & G-SOFT (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)
  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)

Other clearances for product code DYT

  • K864376 — FIBERBOND (April 7, 1987)
  • K812239 — UNITEK PALATAL BAR (September 21, 1981)
  • K780814 — SAFETY STOP NECKSTRAP (June 30, 1978)

FDA data resources