510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770667Substantially Equivalent

Chromascan Tm

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

K770667 is the FDA 510(k) clearance record for CHROMASCAN TM, a class II device, cleared for Sterndent Corp. on under FDA product code KZN (Scanner, Color). FDA records list 2 510(k) clearances for Sterndent Corp., from to . As of , FDA records show no recalls naming K770667.

Clearance record

Decision date
Received
(12 days to decision)
Product code
KZN Scanner, Color
Regulation
21 CFR 872.3661
Device class
Class II
Review panel
Dental
Applicant
Sterndent Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KZN

Trailing 12 months

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

FDA records show no clearances under product code KZN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZN, 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