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510(k) K930202

TITAN SEPARATING SPRING by Ortho Spectrum, Inc. — Product Code DZC

K930202 is an FDA 510(k) premarket notification submitted by Ortho Spectrum, Inc. for the device "TITAN SEPARATING SPRING". The FDA issued a decision of Substantially Equivalent on May 27, 1993. The device falls under product code DZC (Wire, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ortho Spectrum, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
January 14, 1993
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 Ortho Spectrum, Inc.

  • K890962 — ORTHOPAEDIC STAPLES (May 15, 1989)

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)
  • K933376 — NITI ARCH WIRE ON A SPOOL (November 12, 1993)
  • K933379 — STAINLESS STEEL ARCHES (November 12, 1993)

FDA data resources