DeviceClearance

Product code EBI— Dental

DENTURE BASE RESIN

Classification name
Resin, Denture, Relining, Repairing, Rebasing
Device class
Class 2
Regulation
21 CFR 872.3760
Advisory panel
Dental
Total cleared
335
First cleared
Most recent

Market context for product code EBI

FDA has cleared 335 devices under product code EBI between 1978 and 2026, filed by 171 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 EBI

Adverse events under product code EBI

product code EBI
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code EBI

1–100 of 335

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