|
Device |
resin, root canal filling |
Product Code | KIF |
Regulation Number |
872.3820
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/A |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
AVALON BIOMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMTA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY INTERNATIONAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIADENT GROUP INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
DISCUS DENTAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRFP LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRFP LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ESSENTIAL DENTAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENOSS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVATIVE BIOCERAMIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
INNOVATIVE BIOCERAMIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTER-MED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ITENA CLINICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KERR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LUMENDO AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MARUCHI |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
MEDICLUS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
META BIOMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MICRO-MEGA SOCIETE ANONYME |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVOCOL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUSMILE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAXMED INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PREVEST DENPRO LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S & C POLYMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEPTODONT |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SONENDO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPRIG ORAL HEALTH TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYBRON DENTAL SPECIALTIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TYDS BIOTECH INCORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTRADENT PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERICOM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|