|
Device |
resin, denture, relining, repairing, rebasing |
Regulation Description |
Denture relining, repairing, or rebasing resin. |
Product Code | EBI |
Regulation Number |
872.3760
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BELPORT COMPANY, INC., GINGI-PAK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEMDE SA DE CV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DELTAMED GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENTAL DIREKT GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTCA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DETAX GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DK MUNGYO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DREVE DENTAMID GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENLIGHTEN MATERIALS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENVISIONTEC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAPHY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARVEST DENTAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IVOCLAR VIVADENT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KEYSTONE INDUSTRIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYERSON, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAC-DENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISMATIK DENTALCRAFT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRO3DURE MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RITON 3D TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG HUGE DENTAL MATERIAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPRINTRAY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPRINTRAY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRATASYS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERTEX-DENTAL B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VITA ZANHNFABRIK H. RAUTER GMBH CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOCO GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
YAMAHACHI DENTAL MFG., CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIRKONZAHN SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|