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510(k) K933080

ORTHOTECH DURA-GOLD BARCKETS by Orthotech — Product Code EJF

K933080 is an FDA 510(k) premarket notification submitted by Orthotech for the device "ORTHOTECH DURA-GOLD BARCKETS". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Orthotech has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1994
Date Received
June 23, 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 Orthotech

  • K971453 — ORTHOTEC K-CAP SYSTEM (June 24, 1997)

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)
  • 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)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)
  • K926427 — LARIAT PALATE EXPANDER (January 26, 1994)

FDA data resources