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

Powered Tongue Scraper

21 CFR 872.6865 / Dental
FDA source (opens on fda.gov)

QIA is the FDA product code for Powered Tongue Scraper, a class I device type, regulated under 21 CFR 872.6865. FDA's definition for this code reads: "The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QIA
Device name
Powered Tongue Scraper
FDA definition
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.
Regulation
21 CFR 872.6865
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 QIA

By decision year
1 clearance under product code QIA with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QIA by decision year
YearClearances
20191

Applicants with the most clearances

Product code QIA
Applicants holding the most 510(k) clearances under product code QIA
ApplicantClearances
Kea Products, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code