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510(k) K111465

COMPOTHIXO by Kerrhawe SA — Product Code DZN

K111465 is an FDA 510(k) premarket notification submitted by Kerrhawe SA for the device "COMPOTHIXO". The FDA issued a decision of Substantially Equivalent on July 25, 2012. 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
July 25, 2012
Date Received
May 26, 2011
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

  • K071858 — DENTAL MATRIX BAND (August 31, 2007)
  • 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