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
2001-05-17
KLE
2001-02-06
EXCITE DSC
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KLE
2000-11-28
SELF ETCH BONDING PRIMER
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KLE
2000-11-15
SOLOBOND PLUS
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KLE
2000-11-08
CERAM-PRIME
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KLE
2000-08-10
CLEARFIL REPAIR
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KLE
2000-07-07
MODIFICATION TO PROMPT L-POP
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KLE
2000-05-11
PQ1
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KLE
2000-04-28
KERR GEL ETCHANT
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KLE
2000-03-21
BOND 1 C & B
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KLE
2000-02-07
RESIN TOOTH BONDING AGENT
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KLE
2000-02-02
TOKUYAMA ONE-UP-BOND F
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KLE
1999-12-13
PULPDENT UNO-DUO
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KLE
1999-11-29
SURE BOND
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KLE
1999-11-15
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
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KLE
1999-11-09
ECUSIT COMPOSITE REPAIR
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KLE
1999-10-14
GLUMA COMFORT BOND
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KLE
1999-10-01
GLUMA COMFORT BOND + DESENSITIZER
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KLE
1999-08-16
MODIFICATION OF PROMPT L-POP
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KLE
1999-07-09
OPTIBOND SOLO PLUS 2
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KLE
1999-03-19
EXCITE
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KLE
1999-03-08
OPTIBOND SOLO PLUS
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KLE
1999-02-26
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
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KLE
1999-02-25
GLUMA ONE BOND
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KLE
1999-02-04
CLEARFIL SE BOND
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KLE
1999-01-08
PROMPT L-POP
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KLE
1998-12-16
EVERBOND
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KLE
1998-11-30
MODIFICATION OF PQ1
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KLE
1998-11-18
QUADRANT UNIBOND
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KLE
1998-09-21
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
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KLE
1998-07-22
TRUBYTE DENTURE BOND DENTURE BONDING AGENT
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KLE
1998-06-16
GC FUJI BOND LC
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KLE
1998-06-16
ALLOYBOND
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KLE
1998-03-24
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
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KLE
1998-03-23
SOLOBOND M
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KLE
1998-03-23
HURRISEAL DENTIN DESENSITIZER
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KLE
1998-03-03
PREPQUICK
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KLE
1998-02-25
D/SENSE-T
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KLE
1998-02-04
GLUMA ONE BOND
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KLE
1998-01-29
CLEARFIL LINER BOND 2V
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KLE
1998-01-29
PQ 1
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KLE
1997-12-17
ALLOY PRIMER
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KLE
1997-12-08
STAE
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KLE
1997-11-14
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
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KLE
1997-10-07
TOKUSO REBASE MR. BOND
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KLE
1997-10-02
2 BOND 2
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KLE
1997-09-29
SOLITAIRE
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KLE
1997-09-26
KERR NEXUS ONE BOTTLE ADHESIVE
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KLE
1997-09-12
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
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KLE
1997-08-29
EASY BOND
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KLE
1997-08-26
METALPRIMER II
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KLE
1997-06-27
ENCORE BOND
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KLE
1997-05-06
SILOC SYSTEM
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KLE
1997-04-11
HYBRID RESIN COMPOSITE
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KLE
1997-04-02
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
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KLE
1997-02-14
DENTINSENSE B/C
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KLE
1997-02-05
DENTINSENSE
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KLE
1997-01-22
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
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KLE
1997-01-09
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
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KLE
1996-11-05
GLUMA CONDITIONER
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KLE
1996-11-05
BISFIL 2B
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KLE
1996-10-07
GLUMA DESENSITIZER/GLUMA 3 PRIMER
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KLE
1996-09-12
EBS (ESPE BONDING SYSTEM)
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KLE
1996-08-12
3M DENT SYSTEM
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KLE
1996-08-01
KERR ADVANCED ADHESIVE
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KLE
1996-07-18
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
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KLE
1996-07-18
PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
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KLE
1996-07-03
SELF CURE BONDING AGENT
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KLE
1996-06-11
WET-PREP
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KLE
1996-05-06
ULTRACID AND ULTRACID F DISINFECTING SOLUTION
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KLE
1996-04-26
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
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KLE
1996-03-28
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
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KLE
1996-03-28
CONFI-BOND
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KLE
1996-03-22
AMALGAMIBOND PLUS
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KLE
1996-02-08
GLUFLORMA
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KLE
1995-12-28
D-SENSE
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KLE
1995-10-30
SILANE PRIMER
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KLE
1995-10-30
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
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KLE
1995-10-04
IMPERVA ENSURABOND
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KLE
1995-10-04
IMPERVA FLUOROBOND
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KLE
1995-10-03
MICROPRIME
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KLE
1995-09-27
HEMA-BENZ
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KLE
1995-09-27
FUJI BOND LC
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KLE
1995-09-22
MULTI-PRIME AKA/MONO-PRIME
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KLE
1995-09-07
BOND-IT DUAL CURE ACTIVATOR
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KLE
1995-09-07
REVOLUTION BOND
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KLE
1995-08-29
PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS
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KLE
1995-06-20
ABOND
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KLE
1995-06-20
MS EMULSION
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KLE
1995-05-23
PERMAQUIK BONDING PRIMER
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KLE
1995-05-23
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
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KLE
1995-05-12
PERMAQUIK BONDING PRIMER
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KLE
1995-05-12
HEMA-GLU
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KLE
1995-04-10
C&B-METABOND RADIOPAQUE POWDER
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KLE
1995-03-23
PERMALUTE
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KLE
1995-01-03
ECLIPTOMER
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KLE
1994-12-14
PULPDENT DUAL CURE UNFILLED BONDING RESIN
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KLE
1994-11-22
GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER
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KLE
1994-09-09
OPTIBOND-D
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KLE
1994-08-23
PERMAGEN F/DC
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