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510(k) K071858

DENTAL MATRIX BAND by Fly Cast Technologies, Inc. — Product Code DZN

K071858 is an FDA 510(k) premarket notification submitted by Fly Cast Technologies, Inc. for the device "DENTAL MATRIX BAND". The FDA issued a decision of Substantially Equivalent on August 31, 2007. The device falls under product code DZN (Instruments, Dental Hand), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2007
Date Received
July 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Dental Hand
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances for product code DZN

  • K111465 — COMPOTHIXO (July 25, 2012)
  • K901919 — CONTACT MOLAR BANDS AND CONTOUR STRIPS (June 22, 1990)
  • K861581 — CENTRIX PCR MOLAR MATRIX FORMS (BANDS) (May 12, 1986)
  • K844324 — TIGER BAND (December 3, 1984)
  • K840984 — INTERDENTAL WEDGES (April 13, 1984)
  • K822094 — DENTAL MATRIX BAND (August 16, 1982)
  • K821444 — COLORED WEDGE USED TO SEPARATE TEETH (June 14, 1982)
  • K801142 — PALODENT MATRICES & BITINE RINGS (August 7, 1980)
  • K801530 — COREFORM MOLDS (July 28, 1980)
  • K790555 — HEMO-WEDGE (January 17, 1980)

FDA data resources