Material, Tooth Shade, Resin
FDA product code EBF · 909 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.3690
- Review panel
- DE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-11 – 2026-09-21
EBF
1989-12-04
EBF
1989-10-27
CRYSTALLINE C2 AND CRYSTALLINE L3
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EBF
1989-10-20
CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST
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EBF
1989-06-22
KULZER ADHESIVE CEMENT
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EBF
1989-06-16
KULZER INLAY SYSTEM
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EBF
1989-06-09
ZAROLAN, DUALAN, TITAN AND SUPERON
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EBF
1989-05-26
ESPE TULUX-CEM
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EBF
1989-05-19
ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM
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EBF
1989-03-31
CLEARFIL CR INLAY
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EBF
1989-03-29
PHOSPHORIC-ACID ETCHING GEL
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EBF
1989-01-27
HELIOMOLAR(R) DENTAL RESTORATIVE
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EBF
1989-01-03
UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT
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EBF
1989-01-03
PREMET, METAL PRIMER
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EBF
1989-01-03
UNIREST COMPOSITE RESTORATIVE, SELF CURED
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EBF
1988-12-28
UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID
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EBF
1988-12-22
SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED
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EBF
1988-12-07
FIBERLITE, FIBERLITE HS AND FIBERSEAL
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EBF
1988-10-19
VISIO-PERL
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EBF
1988-10-18
LUMINBOND, BONDING AND CEMENTATION SYSTEM
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EBF
1988-08-12
FORTIFY
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EBF
1988-07-15
ACID ETCH GEL
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EBF
1988-07-15
AMORPHUS SILK BY DENTRAX
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EBF
1988-07-01
PROSTHODENT VL
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EBF
1988-06-13
CLEARFIL PHOTO CORE
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EBF
1988-04-18
G-CERA PORCELAIN BOND
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EBF
1988-03-10
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
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EBF
1988-03-02
CLEARFIL PHOTO POSTERIOR
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EBF
1988-02-26
BISCOLOR
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EBF
1988-02-11
DUAL-CURE RADIOPAQUE
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EBF
1988-01-20
LEE COMPOSITE INLAY SYSTEM
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EBF
1988-01-19
OPTEC SUPPLEMENTARY KIT
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EBF
1988-01-12
OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT
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EBF
1987-11-16
CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)
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EBF
1987-11-12
CLEARFIL PORCELAIN REPAIR SYSTEM
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EBF
1987-10-27
#24L SYSTEM
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EBF
1987-09-11
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
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EBF
1987-08-24
DEN-MAT TENURE
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EBF
1987-08-11
CLEARFIL POSTERIOR NEW BOND
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EBF
1987-08-03
DENTIN ADHESIVE
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EBF
1987-08-03
SYNERGY
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EBF
1987-07-21
TEMREX ETCHING GEL
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EBF
1987-07-21
IMPERVA-A
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EBF
1987-07-21
IMPERVA-P
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EBF
1987-07-17
CLEARFIL CORE NEW BOND
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EBF
1987-07-17
CLEARFIL FII NEW BOND
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EBF
1987-07-16
CLEARFIL POSTERIOR 3
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EBF
1987-07-07
PEKALUX(TM)
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EBF
1987-07-02
SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER
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EBF
1987-07-02
PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS
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EBF
1987-07-02
GLUMA(TM) BONDING SYSTEM
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EBF
1987-05-29
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
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EBF
1987-05-29
PERFORM DENTURE BASE RESIN
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EBF
1987-04-03
LUMIFOR(TM) COMPOSITE
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EBF
1987-03-06
MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM
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EBF
1987-02-27
COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM
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EBF
1987-02-19
ESPE CHELON-SILVER
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EBF
1987-02-10
ISOSIT N
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EBF
1987-01-07
REMBRANDT PORCELAIN TINTING KIT
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EBF
1986-11-26
OMNI-FIL
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EBF
1986-11-18
OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE
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EBF
1986-11-13
RECOVER
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EBF
1986-10-17
IMPROVED COMSPAN
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EBF
1986-10-14
MICROFILL PONTIC
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EBF
1986-10-07
CAULK'S POLISHING PASTE
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EBF
1986-09-25
RESTODENT POSTERIOR
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EBF
1986-09-22
MULTIFIL(R) VS
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EBF
1986-09-22
ESTILUX(R) POSTERIOR C
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EBF
1986-09-22
TWIN-CORE
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EBF
1986-09-19
DENTAL COMPOSITE RESTORATIVE
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EBF
1986-09-05
PHOTO CLEARFIL BRIGHT
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EBF
1986-08-18
ESPE VISIO-MOLAR
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EBF
1986-07-29
PANAVIA TC, AND PANAVIA OPAQUE
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EBF
1986-07-22
DEN-MAT DENTIN LINK
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EBF
1986-07-18
V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT
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EBF
1986-07-09
RESTOR (COMET)*DENTAL RESTORATIVE
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EBF
1986-06-25
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
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EBF
1986-05-30
URENAMEL, POSTERIOR RESTORATIVE MATERIAL
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EBF
1986-05-21
P-50 LIGHT CURED RESIN BONDED CERAMIC
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EBF
1986-05-21
REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
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EBF
1986-04-30
BISCO'S PORCELAIN VENEER SYSTEM
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EBF
1986-04-17
PHOTO CLEARFIL OPAQUER
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EBF
1986-04-08
NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID
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EBF
1986-03-26
SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE
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EBF
1986-03-13
RENAMEL ESTHETIC RESTORATIVE SYSTEM
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EBF
1986-03-04
CHAMELEON BONDING KIT
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EBF
1985-11-19
LIGHT CURE FILLING MATERIAL
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EBF
1985-10-31
DENTAL CEMENT
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EBF
1985-09-27
WUNDERSHADE
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EBF
1985-08-16
BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)
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EBF
1985-08-16
BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)
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EBF
1985-08-16
PORCELAIN VENEER SYSTEM BONDING KIT
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EBF
1985-08-16
CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR
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EBF
1985-07-31
RESTORE*
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EBF
1985-07-30
BIOGLOSS
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EBF
1985-07-24
ETEN-GEL
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EBF
1985-07-01
DISTALITE POSTERIA DENTAL RESTORATIVE
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EBF
1985-07-01
PHOTO CURING LIGHT
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EBF
1985-05-21
VISILUX 2 VISIBLE LIGHT CURING UNIT
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EBF
1985-04-22
KULZER DENTIN ADHESIVE
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EBF
1985-04-16
TRIAD C & B MATERIAL
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