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510(k) K925240

FACEBOW by Forestadent Bernhard Forster GmbH — Product Code DZB

K925240 is an FDA 510(k) premarket notification submitted by Forestadent Bernhard Forster GmbH for the device "FACEBOW". The FDA issued a decision of Substantially Equivalent on June 18, 1993. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Forestadent Bernhard Forster GmbH has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1993
Date Received
October 16, 1992
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 Forestadent Bernhard Forster GmbH

  • K110275 — ORTHO EASY PIN (June 3, 2011)
  • K090933 — BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS (June 5, 2009)
  • K924971 — FORESTADENT BRACKETS (May 27, 1993)

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