DeviceClearance

Product code ELM— Dental

ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V

Classification name
Denture, Plastic, Teeth
Device class
Class 2
Regulation
21 CFR 872.3590
Advisory panel
Dental
Total cleared
55
First cleared
Most recent

Market context for product code ELM

FDA has cleared 55 devices under product code ELM between 1977 and 2014, filed by 42 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ELM

Recent clearances under product code ELM

Data sourced from openFDA. This site is unofficial and independent of the FDA.