510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770160Substantially Equivalent

Ceramist Brush

Deringer-Ney, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770160 is the FDA 510(k) clearance record for CERAMIST BRUSH, a class I device, cleared for Deringer-Ney, Inc. on under FDA product code KXR (Applicator, Resin). FDA records list 46 510(k) clearances for Deringer-Ney, Inc., from to . As of , FDA records show no recalls naming K770160.

Clearance record

Decision date
Received
(7 days to decision)
Product code
KXR Applicator, Resin
Regulation
21 CFR 872.3140
Device class
Class I
Review panel
Dental
Applicant
Deringer-Ney, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KXR

Trailing 12 months

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

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