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510(k) K943334

HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT by Jay H. Geller — Product Code DZC

K943334 is an FDA 510(k) premarket notification submitted by Jay H. Geller for the device "HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT". The FDA issued a decision of Substantially Equivalent on October 5, 1994. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Jay H. Geller has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1994
Date Received
July 12, 1994
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 Jay H. Geller

  • K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (May 23, 1997)
  • K942326 — HUMAN C5 RID KITS (August 24, 1995)
  • K950015 — HUMAN PROTEIN C RID TEST KIT (March 6, 1995)

Other clearances for product code DZC

  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • 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)
  • K933380 — REVERSE SURVE NITI ARCH WIRE (November 12, 1993)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)
  • K933379 — STAINLESS STEEL ARCHES (November 12, 1993)

FDA data resources