DeviceClearance

Product code NRQ— Dental

GENERATION 5 LINKOW BLADE IMPLANTS

Classification name
Blade-Form Endosseous Dental Implant
Device class
Class 2
Regulation
21 CFR 872.3640
Advisory panel
Dental
Total cleared
5
First cleared
Most recent

FDA classification definition

“Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.”

— U.S. Food and Drug Administration, device classification record for product code NRQ under 21 CFR 872.3640, via openFDA

Market context for product code NRQ

FDA has cleared 5 devices under product code NRQ between 1979 and 2022, filed by 5 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 NRQ

Recent clearances under product code NRQ

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