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510(k) K771176

GOTHIC ARCH TRACING by Dentsply Intl. — Product Code KZO

K771176 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "GOTHIC ARCH TRACING". The FDA issued a decision of Substantially Equivalent on August 16, 1977. The device falls under product code KZO (Ink, Arch Tracing), a Class I device regulated under 21 CFR 872.3150. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1977
Date Received
June 30, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ink, Arch Tracing
Device Class
Class I
Regulation Number
872.3150
Review Panel
DE
Submission Type

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  • K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC (February 22, 2013)
  • K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (February 14, 2011)
  • K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (October 30, 2009)
  • K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM (May 22, 2009)
  • K082198 — DURASHIELD PLUS (October 29, 2008)
  • K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS (March 27, 2008)
  • K072989 — AXIS SYSTEM (January 28, 2008)
  • K073117 — DENTIN DESENSITIZER AGENT (December 19, 2007)

Other clearances for product code KZO

  • K810972 — THE GNATHOMETER-M (May 5, 1981)

FDA data resources