Product code PFL— Dental

WIRED MOUTH PROTECTOR (WMP)

Classification name: Intraoral, Dental Foam Protector
Device class: Class 1
Regulation: 21 CFR 872.6890
Advisory panel: Dental
Total cleared: 1
First cleared: 2013-09-30
Most recent: 2013-09-30

FDA classification definition

“Intended to provide a soft barrier between wired mouth hardware and oral mucosa.”
— U.S. Food and Drug Administration, device classification record for product code PFL under 21 CFR 872.6890, via openFDA

Market context for product code PFL

FDA has cleared 1 device under product code PFL, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PFL

Elba Laboratories, Inc.1 clearance

Recent clearances under product code PFL

K131396 — WIRED MOUTH PROTECTOR (WMP)Elba Laboratories, Inc.·2013-09-30

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