PFL · Class I · 21 CFR 872.6890

FDA Product Code PFL: Intraoral, Dental Foam Protector

Intended To Provide A Soft Barrier Between Wired Mouth Hardware And Oral Mucosa.

Leading manufacturers include Elba Laboratories, Inc..

1
Total
1
Cleared
138d
Avg days
2013
Since

FDA 510(k) Cleared Intraoral, Dental Foam Protector Devices (Product Code PFL)

1 devices
1–1 of 1
Cleared Sep 30, 2013
WIRED MOUTH PROTECTOR (WMP)
K131396
Elba Laboratories, Inc.
Dental · 138d

About Product Code PFL - Regulatory Context