510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771176Substantially Equivalent

Gothic Arch Tracing

Dentsply Intl., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771176 is the FDA 510(k) clearance record for GOTHIC ARCH TRACING, a class I device, cleared for Dentsply Intl. on under FDA product code KZO (Ink, Arch Tracing). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K771176.

Clearance record

Decision date
Received
(47 days to decision)
Product code
KZO Ink, Arch Tracing
Regulation
21 CFR 872.3150
Device class
Class I
Review panel
Dental
Applicant
Dentsply Intl. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KZO

Trailing 12 months

FDA records hold no clearances under product code KZO in the trailing twelve months.

FDA records show no clearances under product code KZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260