510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K940244Substantially Equivalent

Verident Plus, Optiform

Lactona Corp., Montgomeryville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940244 is the FDA 510(k) clearance record for VERIDENT PLUS, OPTIFORM, a class II device, cleared for Lactona Corp. on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list one 510(k) clearance for Lactona Corp. As of , FDA records show no recalls naming K940244.

Clearance record

Decision date
Received
(103 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Lactona Corp. 201 Commerce Dr., Montgomeryville PA
510(k) summary
Statement
Third party review
No

Clearances, product code ELM

Trailing 12 months

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

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