510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770064Substantially Equivalent

Fluoride Gel Disposable Tray

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

K770064 is the FDA 510(k) clearance record for FLUORIDE GEL DISPOSABLE TRAY, a class I device, cleared for Lorvic Corp. on under FDA product code KMT (Tray, Fluoride, Disposable). FDA records list 6 510(k) clearances for Lorvic Corp., from to . As of , FDA records show no recalls naming K770064.

Clearance record

Decision date
Received
(3 days to decision)
Product code
KMT Tray, Fluoride, Disposable
Regulation
21 CFR 872.6870
Device class
Class I
Review panel
Dental
Applicant
Lorvic Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KMT

Trailing 12 months

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

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