|
Device |
material, tooth shade, resin |
Product Code | EBF |
Regulation Number |
872.3690
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3M COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
3M COMPANY ESPE DENTAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M ESPE DENTAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AB ARDENT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANAXDENT GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APEX DENTAL MATERIALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BICON, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIODEN CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLOREN S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLOREN SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BISCO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BREDENT GMBH & CO.KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENDRES+METAUX SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLTENE/WHALEDENT AG |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
COSMEDENT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
COSMEDENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CREAMED GMBH & CO. PRODUKTIONS- UND HANDELS KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANVILLE MATERIALS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANVILLE MATERIALS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DANVILLE MATERIALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DANVILLE MATERIALS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DELTAMED GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEN-MAT HOLDINGS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENALI CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTKIST, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSCARE LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DENTSPLY INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DETAX GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIADENT GROUP INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DISCUS DENTAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DMG USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DMG USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DMP LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DWS S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENVISIONTEC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIGARO CROWNS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GC AMERICA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GC AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GENOSS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENOSS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAPHENANO DENTAL S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAPHY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GREENWAY YW LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HDI, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS KULZER, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS KULZER, LLC (MITSUI CHEMICALS GROUP) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ITENA CLINICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVOCLAR VIVADENT AG |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
IVOCLAR VIVADENT, AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVOCLAR VIVADENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
JUNO DENTISTRY LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KERR CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KERR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
KETTENBACH GMBH & CO KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KULZER, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KURARAY AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KURARAY MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KURARAY NORITAKE DENTAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
KURARAY NORITAKE DENTAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIAONING UPCERA CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERZ DENTAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
META BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANOVA BIOMATERIALS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOVA BIOMATERIALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOBIO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVOCOL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PAC-DENT INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAC-DENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARKELL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PASCAL CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTRON CLINICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTRON CLINICAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERFECT FIT CROWNS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PREMIER DENTAL PRODUCTS COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PREVEST DENPRO LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISMATIK DENTALCRAFT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PULPDENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
RELIANCE ORTHODONTIC PRODUCTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RHONDIUM, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RIZHAO HUGE BIOMATERIALS COMPANY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITATEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAREMCO DENTAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCHUETZ DENTAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHUTZ DENTAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SDI LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHOFU DENTAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHOFU DENTAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
SILMET LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPIDENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SPRINTRAY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SWISSMEDITEC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYBRON DENTAL SPECIALTIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYBRON DENTAL SPECIALTIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOKUYAMA DENTAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ULTRADENT PRODUCT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRADENT PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VERICOM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOCO GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
24
|
1. K090843 AMARIS GINGIVA OPAQUER
|
2. K101213 GRANDIO FLOW
|
3. K102351 GRANDIO SO
|
4. K102354 GRANDIO SO HEAVY FLOW
|
5. K102450 IONOLUX PRO
|
6. K103580 GRANDIO SO FLOW
|
7. K110589 CIMARA
|
8. K112374 X-TRA BASE
|
9. K112447 GRANDIO CORE DUAL CURE
|
10. K113444 N-HYBRIDE-COMPOSITE LC FLOW
|
11. K113563 N-HYBRIDE-COMPOSITE LC
|
12. K123773 X-TRA BASE
|
13. K150784 Admira Fusion
|
14. K151956 Admira Fusion x-tra
|
15. K153177 Admira Fusion Flow
|
16. K153493 Clip Flow
|
17. K170896 Admira Fusion x-base
|
18. K171200 Grandio blocs
|
19. K171815 Registrado Scan
|
20. K181312 GrandioSO x-tra
|
21. K190453 VisCalor bulk
|
22. K200294 GrandioSO Light Flow
|
23. K201307 VisCalor
|
24. K230877 Admira Fusion 5
|
ZIRKONZAHN SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|