|
Device |
resin, denture, relining, repairing, rebasing |
Product Code | EBI |
Regulation Number |
872.3760
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BELPORT COMPANY, INC., GINGI-PAK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BISCO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLEMDE SA DE CV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CMP INDUSTRIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMFORT AND FLEXIBLE SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DELTAMED GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENTAL DIREKT GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAL SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTCA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DENTSOLL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DETAX GMBH & CO. KG |
|
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
|
GC AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBAL DENTAL SCIENCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAPHY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GREAT LAKES ORTHODONTICS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HARVEST DENTAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HERAEUS KULZER, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IVOCLAR VIVADENT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVOCLAR VIVADENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JUELL DENTAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JUVORA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JUVORA, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KOREA ENGINEERING PLASTICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANG DENTAL MANUFACTURING CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANG DENTAL MANUFACTURING COMPANY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANG DENTAL MFG. CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERZ DENTAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MYCONE DENTAL SUPPLY CO., T/A KEYSTONE INDUSTRIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYCONE DENTAL SUPPLY COMPANY, INC. (AKA KEYSTONE INDUSTRIES) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYERSON, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW STETIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUXEN S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PAC-DENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARK DENTAL RESEARCH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERFLEX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISMATIK DENTALCRAFT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRO3DURE MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROTECH PROFESSIONAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
|
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
|
SUN MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUN MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNCA MARKETING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE MYERSON COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THERMOPLASTIC COMFORT SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOKUYAMA DENTAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
UNIX-JAPAN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERTEX-DENTAL B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
VERTEX-DENTAL BV |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VITA ZANHNFABRIK H. RAUTER GMBH CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOCO GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
WHIP MIX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YAMAHACHI DENTAL MANUFACTURING CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YAMAHACHI DENTAL MFG., CO. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZEST ANCHORS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIRKONZAHN SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|