DeviceClearance

Product code EBO— Dental

COMPLETE DENTURE REPAIR KIT

Classification name
Denture Repair Kit
Device class
Class 2
Regulation
21 CFR 872.3570
Advisory panel
Dental
Total cleared
7
First cleared
Most recent

FDA classification definition

“This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

— U.S. Food and Drug Administration, device classification record for product code EBO under 21 CFR 872.3570, via openFDA

Market context for product code EBO

FDA has cleared 7 devices under product code EBO between 1977 and 1985, filed by 6 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

Top applicants under product code EBO

Recent clearances under product code EBO

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