Agent, Tooth Bonding, Resin
FDA product code KLE · 404 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.3200
- Review panel
- DE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-03 – 2026-09-24
KLE
2009-03-31
KLE
2009-01-21
IBOND TOTAL ETCH
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KLE
2008-12-11
BEAUTIBOND
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KLE
2008-11-24
FUTURABOND M/FUTURABOND M SINGLE DOSE
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KLE
2008-10-21
G-BOND PLUS
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KLE
2007-11-21
GENERATION 8 SE ADHESIVE
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KLE
2007-09-07
RELIANCE S.E.P.
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KLE
2007-08-10
NANO-BOND II ADHESIVE SYSTEM
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KLE
2007-07-25
UNO
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KLE
2007-07-17
HERMES BOND 3
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KLE
2007-07-09
FL BOND II
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KLE
2007-06-07
FUTURABOND DC/SINGLE DOSE
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KLE
2007-05-22
SEA2 SELF ETCH ADHESIVE
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KLE
2007-05-11
ADHESE ONE
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KLE
2007-04-26
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
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KLE
2007-03-30
TOKUYAMA BOND FORCE
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KLE
2007-03-20
TOTAL ETCH BONDING AGENT
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KLE
2007-03-14
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
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KLE
2007-01-19
ACE BOND SE
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KLE
2006-12-14
PEAK SE, MODEL 5135
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KLE
2006-12-12
PEAK BOND, MODEL 5133
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KLE
2006-12-01
HKBOND 2006
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KLE
2006-11-02
ADHESIVE DC ACTIVATOR
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KLE
2006-10-04
PREMIER SELF-ETCHING BOND ENHANCER
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KLE
2006-09-27
CLEARFIL DC BOND
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KLE
2006-09-11
BOSWORTH DENTIN RESIN
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KLE
2006-09-01
EXCEL BOND DC, MODEL 28-200100
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KLE
2006-07-31
SURPASS
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KLE
2006-06-02
PORCELAIN PRIMER
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KLE
2006-04-24
ADPER PROMPT, ADPER PROMPT L-POP
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KLE
2006-03-28
OPTIBOND ALL-IN-ONE
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KLE
2006-02-01
INTERFACE
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KLE
2005-12-15
FUTURABOND NR SINGLE DOSE
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KLE
2005-11-16
VERSA-LINK PORCELAIN BONDING SYSTEM
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KLE
2005-10-21
MULTIPLE RESIN TOOTH BONDING AGENT
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KLE
2005-10-17
REVENEER CERAMIC REPAIR SYSTEM
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KLE
2005-08-09
CLEARFIL TRI-S BOND SINGLE DOSE
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KLE
2005-07-15
ECLIPSE BONDING AGENT
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KLE
2005-07-12
XENO ADHESIVE WITH ACTIVATOR
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KLE
2005-06-29
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
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KLE
2005-06-07
IBOND NEXT GENERATION
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KLE
2005-04-20
ALL-IN-ONE
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KLE
2005-03-24
ADHESIVE 1
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KLE
2005-02-25
BOSWORTH BOND
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KLE
2005-02-23
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
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KLE
2005-01-10
HERMES BOND 2
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KLE
2005-01-03
BC PLUS
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KLE
2004-11-26
CLEARFIL TRI-S BOND
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KLE
2004-11-24
QUADRANT UNIT-1-BOND
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KLE
2004-11-22
S&C-SELF ETCH PR-BOND
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KLE
2004-11-10
ORAJEL ADVANCED TOOTH DESENSITIZER
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KLE
2004-11-01
FUTURABOND NR
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KLE
2004-09-09
M.L. PRIMER
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KLE
2004-08-30
COMPOSITE/COMPOMER REPAIR KIT
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KLE
2004-06-29
G-BOND
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KLE
2004-06-29
PRELUDE
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KLE
2004-06-16
XENO NM LIGHT CURED DENTAL ADHESIVE
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KLE
2004-05-10
MODIFICATION TO ADPER PROMPT
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KLE
2004-02-06
HERMES BOND
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KLE
2004-01-29
CLEARFIL PROTECT BOND
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KLE
2004-01-23
ONE COAT SE BOND
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KLE
2003-12-10
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
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KLE
2003-12-03
PERMAQUICK SE BONDING SYSTEM
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KLE
2003-09-09
COMP. E
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KLE
2003-08-05
PULPDENT ETCH-RITE ROYALE
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KLE
2003-07-02
OPTIBOND FL
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KLE
2003-06-13
FINAL VARNISH LC
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KLE
2003-05-09
ETCHANT 40%
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KLE
2003-03-26
CLEARFIL SILANE KIT
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KLE
2003-02-11
CLEARFIL SE BOND PLUS
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KLE
2003-01-23
XENO III DENTAL ADHESIVE
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KLE
2002-11-22
ADHESIVE 14
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KLE
2002-10-28
PQ1
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KLE
2002-10-28
IBOND GLUMA INSIDE
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KLE
2002-06-07
CLEARFIL SA PRIMER
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KLE
2002-05-16
PULPDENT GLAZE II
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KLE
2002-04-24
SIMPLICITY
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KLE
2002-04-22
BOND-3 ADHESIVE
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KLE
2002-04-19
XR PRIMER 2
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KLE
2002-04-04
ADPER PROMPT
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KLE
2002-03-20
TOUCH&BOND-PLUS
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KLE
2002-02-22
OPTIBOND SOLO PLUS 4
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KLE
2002-02-22
BOND-1 C & B
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KLE
2002-02-20
UNIFIL BOND
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KLE
2002-02-14
ENAMEL BONDING SYSTEM
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KLE
2002-02-14
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
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KLE
2002-01-28
EXCITE SELF ETCH
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KLE
2002-01-17
SIMPLE
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KLE
2001-09-20
OPTIBOND SOLO PLUS ACTIVATOR
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KLE
2001-09-14
CLEARFIL NEW BOND
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KLE
2001-09-13
CLEARFIL PORCELAIN BOND ACTIVATOR
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KLE
2001-09-13
CLEARFIL REPAIR
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KLE
2001-09-10
MODIFICATION TO CLEARFIL SE BOND
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KLE
2001-09-05
MODIFICATION TO CLEARFIL LINER BOND 2V
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KLE
2001-09-04
MODIFICATION TO ALLOY PRIMER
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KLE
2001-09-04
MODIFICATION TO CLEARFIL PHOTO BOND
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KLE
2001-08-30
OPTIBOND 2
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KLE
2001-08-16
VERTEX SEALAND L/C ORTHODONTIC SEALANT
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KLE
2001-07-23
ISODAN
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KLE
2001-06-27
MODIFICATION TO EXCITE
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