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510(k) K936151

EXTRAORAL HEADGEAR by Dentauraum, Inc. — Product Code DZB

K936151 is an FDA 510(k) premarket notification submitted by Dentauraum, Inc. for the device "EXTRAORAL HEADGEAR". The FDA issued a decision of Substantially Equivalent on August 1, 1994. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Dentauraum, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1994
Date Received
December 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

Other clearances by Dentauraum, Inc.

  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952870 — REMANIUM: CS & G-SOFT (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)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K942666 — ORTHALGENAT IMPRESSION MATERIAL (August 10, 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 DZB

  • K202855 — Orthodontic Facemask (June 21, 2021)
  • K162543 — Reverse Pull Adjustable Facemask (August 28, 2017)
  • K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-P (October 3, 2011)
  • K103019 — KJ MASK (June 9, 2011)
  • K052553 — NITOM LOCKING FACEBOW (December 22, 2005)
  • K051751 — EQUA-PULL SAFETY RELEASE MODULE (July 22, 2005)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K032392 — MORALES PROTRACTION FACEMASK (October 22, 2003)
  • K000358 — MULTI ADJUSTABLE FACE MASK (June 9, 2000)
  • K993224 — T-GEAR, MODEL TG/400-700 (February 11, 2000)

FDA data resources