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510(k) K851878

A COMPANY BRASS SEPARATING RINGS by A Company, Inc. — Product Code DZC

K851878 is an FDA 510(k) premarket notification submitted by A Company, Inc. for the device "A COMPANY BRASS SEPARATING RINGS". The FDA issued a decision of Substantially Equivalent on June 5, 1985. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. A Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
April 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by A Company, Inc.

  • K897195 — A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) (May 31, 1990)
  • K852596 — A-COMPANY ELASTIC LIGATURE RINGS (July 31, 1985)
  • K852597 — A-COMPANY ELASTIC ROTATION WEDGES (July 31, 1985)
  • K852599 — A-COMPANY ELASTOMERIC TUBING (July 31, 1985)
  • K852600 — A-COMPANY ELASTOMERIC CHAIN DISPENSER (July 31, 1985)
  • K852598 — A-COMPANY SEPARATING ELASTICS (July 31, 1985)
  • K852800 — A-COMPANY SELF-LIGATING APPLIANCE (July 31, 1985)
  • K852670 — A-COMPANY ESPREE SAFETY HEADGEAR (July 31, 1985)
  • K851454 — A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS (April 29, 1985)
  • K844067 — VANISH ORTHODONTIC BRACKET (November 23, 1984)

Other clearances for product code DZC

  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (October 5, 1994)
  • K935638 — NITINOL, NITI (May 18, 1994)
  • K935140 — DENTAURUM STEEL LIGATURE WIRES (February 4, 1994)
  • K935142 — DENTAURUM WIRES (January 31, 1994)
  • K934265 — FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (January 21, 1994)
  • K933374 — NITI COIL SPRINGS (November 19, 1993)
  • K933377 — STAINLESS STEEL ARCHES REPACKER RELABETER (November 16, 1993)
  • K933379 — STAINLESS STEEL ARCHES (November 12, 1993)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)

FDA data resources