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510(k) K780170

ORTHODONTIC BRACKET PADS by Rocky Mountain Orthodontics, Inc. — Product Code EJF

K780170 is an FDA 510(k) premarket notification submitted by Rocky Mountain Orthodontics, Inc. for the device "ORTHODONTIC BRACKET PADS". The FDA issued a decision of Substantially Equivalent on March 15, 1978. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Rocky Mountain Orthodontics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1978
Date Received
February 2, 1978
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 Rocky Mountain Orthodontics, Inc.

  • K895401 — NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM (December 4, 1989)
  • K843527 — ORTHOMITE 111 ADHESIVE (October 18, 1984)
  • K780678 — IMPRESSION TRAY (April 28, 1978)
  • K780334 — ADHESIVE, BRACKET AND CONDITIONER RESIN (March 28, 1978)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

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)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources