510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K022300Substantially Equivalent

Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.h., Vipi Dent V

Dental Vipi Ltda, Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022300 is the FDA 510(k) clearance record for ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V, a class II device, cleared for Dental Vipi Ltda on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list one 510(k) clearance for Dental Vipi Ltda. As of , FDA records show no recalls naming K022300.

Clearance record

Decision date
Received
(79 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Dental Vipi Ltda 13 Red Fox Ln., Littleton CO
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