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510(k) K924971

FORESTADENT BRACKETS by Forestadent Bernhard Forster GmbH — Product Code EJF

K924971 is an FDA 510(k) premarket notification submitted by Forestadent Bernhard Forster GmbH for the device "FORESTADENT BRACKETS". The FDA issued a decision of Substantially Equivalent on May 27, 1993. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Forestadent Bernhard Forster GmbH has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
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)
  • K925240 — FACEBOW (June 18, 1993)

Other clearances for product code EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K923372 — MEMORY WIRE (April 22, 1994)
  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)

FDA data resources