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510(k) K936243

REGENCY TUBE by Ortho Specialties — Product Code DZD

K936243 is an FDA 510(k) premarket notification submitted by Ortho Specialties for the device "REGENCY TUBE". The FDA issued a decision of Substantially Equivalent on February 2, 1994. The device falls under product code DZD (Tube, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ortho Specialties has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1994
Date Received
December 30, 1993
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 Ortho Specialties

  • K140807 — COMPOSITE ORTHODONTIC BRACKETS (November 12, 2014)

Other clearances for product code DZD

  • K943421 — ORTHODONITC ELASTOMERIC SLEEVING (May 23, 1995)
  • 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