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510(k) K934881

REFLECTIONS by Cdb Corp. — Product Code EJF

K934881 is an FDA 510(k) premarket notification submitted by Cdb Corp. for the device "REFLECTIONS". The FDA issued a decision of Substantially Equivalent on February 1, 1994. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Cdb Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1994
Date Received
October 12, 1993
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 Cdb Corp.

  • K973776 — REFLECTIONS (November 21, 1997)
  • K922499 — REFLECTIONS - CERAMIC DENTAL BRACKET (July 30, 1992)

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)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources