|
Device |
aligner, sequential |
Regulation Description |
Orthodontic plastic bracket. |
Definition |
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. |
Product Code | NXC |
Regulation Number |
872.5470
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3D DIAGNOSTIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3D GLOBAL BIOTECH INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3D SMILE USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M COMPANY, UNITEK ORTHODONTIC PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALIEN MILLING TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALIGN TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
AMPA ORTHODONTICS PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARCADLAB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARGEN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARKLIGN LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASO INTERNATIONAL MANILA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTECH DENTAL SMILERS, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLUE SKY BIO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BRIUS TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CDB CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEAR MOVES ALIGNERS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEARCORRECT LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEARCORRECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEARPATH ORTHODONTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CREODENT PROSTHETICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CRISTALINE ALIGNERS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTCARE DENTAL LAB PVT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTIS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAKE PRECISION DENTAL LABORATORY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DROR ORTHODESIGN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENSMILE PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EON DENTAL JORDAN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENIOVA TECHNOLOGIES SOCIEDAD LIMITADA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAPHY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GRUPPO EUROPEO ORTODONZIA SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INMAN ORTHODONTIC LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOHNS DENTAL LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K LINE EUROPE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KEY DENTAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAXMI DENTAL EXPORT PVT. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAXMI DENTAL EXPORTS PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUXCREO INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MODERN DENTAL LABORATORY (DG) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOTOR CITY LAB WORKS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MVP ALIGNERS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANJING JIAHE DENTAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW ENGLAND ORTHO LAB, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW ENGLAND ORTHO LAB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OHLENDORF APPLIANCE LABORATORY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORAL IMAGE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORDONT ORTHODONTIC LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORMCO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHO LAB SERVICES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARK DENTAL RESEARCH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PEARL DIGITAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERFECTION ALIGNER SYSTEM HONG KONG LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION ALIGN LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROYAL DENTAL LAB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MEIMING DENTISTRY TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YINUO DENTAL TECHNOLOGY CO.LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMS OPCO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMYLIO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMYLIO, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPACE MAINTAINERS LABORATORIES (SML) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STR8 ORAL CARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRAIGHT T, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TNS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TP ORTHODONTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULAB SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNIVERSAL ORTHODONTIC LABORATORY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UTAH MEDICAL PRODUCTS AND SERVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITANG TECHNOLOGY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XPLORA 3D EUROPE S.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|