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510(k) K943421

ORTHODONITC ELASTOMERIC SLEEVING by Jon-Ko Products, Inc. — Product Code DZD

K943421 is an FDA 510(k) premarket notification submitted by Jon-Ko Products, Inc. for the device "ORTHODONITC ELASTOMERIC SLEEVING". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code DZD (Tube, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Jon-Ko Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1995
Date Received
July 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Jon-Ko Products, Inc.

  • K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE (May 24, 1995)
  • K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD (May 23, 1995)
  • K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (May 23, 1995)
  • K943420 — ORTHODONTIC ELASTOMERIC CHAIN (May 23, 1995)

Other clearances for product code DZD

  • K936243 — REGENCY TUBE (February 2, 1994)
  • K935143 — DENTAURUM STAINLESS STEEL TUBING (January 31, 1994)
  • K911399 — NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (September 19, 1991)
  • K896586 — RATE INCREASE FOR IPPB/IPV (January 9, 1990)
  • K834446 — ALEXOTEK LINGUAL TUBES (April 5, 1984)
  • K834392 — LABIAL CUSPID TUBE (February 28, 1984)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

FDA data resources