510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QJJClass I

Indirect Bonding Tray

21 CFR 872.5410 / Dental
FDA source (opens on fda.gov)

QJJ is the FDA product code for Indirect Bonding Tray, a class I device type, regulated under 21 CFR 872.5410. FDA's definition for this code reads: "A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QJJ
Device name
Indirect Bonding Tray
FDA definition
A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.
Regulation
21 CFR 872.5410
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
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order