DeviceClearance

Product code NPK— Dental

STRAUMANN MEMBRAGEL

Classification name
Barrier, Synthetic, Intraoral
Device class
Class 2
Regulation
21 CFR 872.3930
Advisory panel
Dental
Total cleared
31
First cleared
Most recent

FDA classification definition

“A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.”

— U.S. Food and Drug Administration, device classification record for product code NPK under 21 CFR 872.3930, via openFDA

Market context for product code NPK

FDA has cleared 31 devices under product code NPK between 1986 and 2023, filed by 21 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 NPK

Recent clearances under product code NPK

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