510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PFLClass I

Intraoral, Dental Foam Protector

21 CFR 872.6890 / Dental
FDA source (opens on fda.gov)

PFL is the FDA product code for Intraoral, Dental Foam Protector, a class I device type, regulated under 21 CFR 872.6890. FDA's definition for this code reads: "Intended to provide a soft barrier between wired mouth hardware and oral mucosa". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PFL
Device name
Intraoral, Dental Foam Protector
FDA definition
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Regulation
21 CFR 872.6890
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PFL

By decision year
1 clearance under product code PFL with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFL by decision year
YearClearances
20131

Applicants with the most clearances

Product code PFL
Applicants holding the most 510(k) clearances under product code PFL
ApplicantClearances
Elba Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code