|
Device |
adhesive, bracket and tooth conditioner, resin |
Product Code | DYH |
Regulation Number |
872.3750
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3M UNITEK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M UNITEK CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M UNITEK ORTHODONTIC PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMERICAN ORTHODONTICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BISCO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANVILLE MATERIALS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DAVILLE MATERIALS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSCARE LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY INTL., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GC ORTHODONTICS AMERICA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LARGENT HEALTH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVOCOL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULPDENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE ORTHODONTIC PRODUCTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K161684 Quantum LB
|
2. K193388 GlassLok Kits, GlassLok Powder, GlassLok Liquid
|
RELIANCE ORTHODONTIC PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TP ORTHODONTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRADENT PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
VOCO GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|