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

Composite Resin Warmer

21 CFR 872.6100 / Dental
FDA source (opens on fda.gov)

QGO is the FDA product code for Composite Resin Warmer, a class I device type, regulated under 21 CFR 872.6100. FDA's definition for this code reads: "Intended to warm composite materials prior to use". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QGO
Device name
Composite Resin Warmer
FDA definition
Intended to warm composite materials prior to use
Regulation
21 CFR 872.6100
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 QGO

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

Applicants with the most clearances

Product code QGO
Applicants holding the most 510(k) clearances under product code QGO
ApplicantClearances
Addent, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code