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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
DZS
Capsule, Dental, Amalgam
1
Product Code
DYH
Adhesive, Bracket And Tooth Conditioner, Resin
2
Product Code
DZE
Implant, Endosseous, Root-Form
2
Product Code
EBC
Sealant, Pit And Fissure, And Conditioner
2
Product Code
EBD
Coating, Filling Material, Resin
2
Product Code
EBE
Coating, Denture Hydrophilic, Resin
2
Product Code
EBF
Material, Tooth Shade, Resin
2
Product Code
EBG
Crown And Bridge, Temporary, Resin
2
Product Code
EBH
Material, Impression Tray, Resin
1
Product Code
EBI
Resin, Denture, Relining, Repairing, Rebasing
2
Product Code
EBL
Pin, Retentive And Splinting, And Accessory Instruments
1
Product Code
EBO
Denture Repair Kit
2
Product Code
EBP
Reliner, Denture, Over The Counter
2
Product Code
EFD
Amalgamator, Dental, Ac-Powered
1
Product Code
EFT
Cleanser, Denture, Over The Counter
1
Product Code
EGG
Attachment, Precision, All
1
Product Code
EHE
Dispenser, Mercury And/Or Alloy
1
Product Code
EHO
Bar, Preformed
1
Product Code
EHP
Clasp, Preformed
1
Product Code
EHQ
Cusp, Preformed
1
Product Code
EHR
Pad, Denture, Over The Counter
2
Product Code
EHS
Cushion, Denture, Over The Counter
2
Product Code
EIT
Applicator, Rapid Wax, Dental
2
Product Code
EJH
Alloy, Metal, Base
2
Product Code
EJJ
Alloy, Amalgam
2
Product Code
EJK
Liner, Cavity, Calcium Hydroxide
2
Product Code
EJL
Bur, Dental
1
Product Code
EJP
Articulators
1
Product Code
EJS
Alloy, Other Noble Metal
2
Product Code
EJT
Alloy, Gold-Based Noble Metal
2
Product Code
EJW
Clasp, Wire
1
Product Code
EJX
Anchor, Preformed
1
Product Code
EKL
Point, Silver, Endodontic
1
Product Code
EKM
Gutta-Percha
1
Product Code
EKN
Point, Paper, Endodontic
1
Product Code
EKO
Denture Preformed (Partially Prefabricated Denture)
2
Product Code
ELE
Implant, Subperiosteal
2
Product Code
ELJ
Teeth, Artificial, Posterior With Metal Insert
1
Product Code
ELK
Teeth, Artificial, Backing And Facing
1
Product Code
ELL
Teeth, Porcelain
2
Product Code
ELM
Denture, Plastic, Teeth
2
Product Code
ELN
Teeth, Preformed Gold Denture
1
Product Code
ELO
Cusp, Gold And Stainless Steel
1
Product Code
ELR
Post, Root Canal
1
Product Code
ELS
Splint, Endodontic Stabilizing
2
Product Code
ELW
Material, Impression
2
Product Code
ELY
Mercury
2
Product Code
ELZ
Crown, Preformed
1
Product Code
EMA
Cement, Dental
2
Product Code
EMB
Zinc Oxide Eugenol
1
Product Code
JER
Cleaner, Denture, Mechanical
1
Product Code
KCR
Facebow
1
Product Code
KCS
Pantograph
1
Product Code
KIF
Resin, Root Canal Filling
2
Product Code
KLE
Agent, Tooth Bonding, Resin
2
Product Code
K
24
2749
TopCEM Ceramic Primer Ceramic Coupling Agent
2
Cleared 510(K)
K
24
2675
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
2
Cleared 510(K)
K
24
0153
Ceramic Etchant (HF-5 and HF-9)
2
Cleared 510(K)
K
24
1445
K-Bond Universal
2
Cleared 510(K)
K
24
1056
Light Cure Adhesive
2
Cleared 510(K)
K
24
0743
Peak Universal Bond
2
Cleared 510(K)
K
23
1039
CLEARFIL Universal Bond Quick 2
2
Cleared 510(K)
K
23
2978
DX. Bond V Dental Bonding Adhesive
2
Cleared 510(K)
K
23
1696
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
2
Cleared 510(K)
K
23
0465
Hi-Bond Universal
2
Cleared 510(K)
K
23
0009
EZ Bond Universal
2
Cleared 510(K)
K
22
2830
Rainbow 360
2
Cleared 510(K)
K
22
1450
Phosphoric Acid Etching Gel
2
Cleared 510(K)
K
22
2357
DenMat Glutaraldehyde Desensitizer
2
Cleared 510(K)
K
22
1033
UniPrime A, UniPrime E, UniPrime E/C
2
Cleared 510(K)
K
22
0804
Dia-X Bond Universal
2
Cleared 510(K)
K
21
0804
Adhese Universal DC, Cention Primer
2
Cleared 510(K)
K
21
3965
BeautiBond Xtreme
2
Cleared 510(K)
K
21
3401
DIAPLUS Universal
2
Cleared 510(K)
K
21
3093
STEP-1 PumEtch
2
Cleared 510(K)
K
21
0186
PacBond One
2
Cleared 510(K)
K
21
0945
Ultra SEP
2
Cleared 510(K)
K
20
3760
Tokuyama Universal Bond II
2
Cleared 510(K)
K
19
2913
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
2
Cleared 510(K)
K
20
0153
Bright Bond Universal
2
Cleared 510(K)
K
20
0682
BZF-29
2
Cleared 510(K)
K
20
1787
Light Cure Dental Adhesive
2
Cleared 510(K)
K
20
0462
EtchPro Etching Gel
2
Cleared 510(K)
K
19
2392
DiaPlus
2
Cleared 510(K)
K
19
2273
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
2
Cleared 510(K)
K
18
3424
Ambar, Ambar APS, Ambar Universal APS
2
Cleared 510(K)
K
19
1656
Zipbond
2
Cleared 510(K)
K
19
2961
ADH19
2
Cleared 510(K)
K
19
1523
Visalys Restorative Primer
2
Cleared 510(K)
K
19
1524
Visalys Tooth Primer
2
Cleared 510(K)
K
18
3391
Novidia Universal Bond
2
Cleared 510(K)
K
18
0917
GC Acrylic Primer
2
Cleared 510(K)
K
18
2162
OptiBond eXTRa Universal
2
Cleared 510(K)
K
18
1910
BracePaste MTP Light Cure Primer
2
Cleared 510(K)
K
18
1476
Prime&Bond active Universal Adhesive
2
Cleared 510(K)
K
18
0803
BeautiBond Universal
2
Cleared 510(K)
K
18
0802
Meta P&Bond
2
Cleared 510(K)
K
17
2953
Acid Etchant
2
Cleared 510(K)
K
17
2977
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
2
Cleared 510(K)
K
17
1226
TOKUYAMA UNIVERSAL BOND
2
Cleared 510(K)
K
17
2176
Parkell Universal Adhesive
2
Cleared 510(K)
K
17
2106
SHOFU MZ Primer Plus
2
Cleared 510(K)
K
16
1077
RnD TE and RnD SE
2
Cleared 510(K)
K
16
1891
HC Primer
2
Cleared 510(K)
K
16
1042
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
2
Cleared 510(K)
K
16
1051
All-Bond Universal w/BAC (not finalized)
2
Cleared 510(K)
K
15
2243
One Coat 7 Universal
2
Cleared 510(K)
K
15
2110
e-1 etchants
2
Cleared 510(K)
K
15
1619
Prime&Bond Elect Universal Dental Adhesive
2
Cleared 510(K)
K
15
1518
BRUSH&BOND PLUS
2
Cleared 510(K)
K
15
0703
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
2
Cleared 510(K)
K
15
0933
iBond Universal & iBond Ceramic Primer
2
Cleared 510(K)
K
15
0696
Jade 37% Phosphoric Acid Etchant Gel
2
Cleared 510(K)
K
14
3140
G-Premio BOND
2
Cleared 510(K)
K
15
0164
Monobond Etch & Prime
2
Cleared 510(K)
K
14
2848
EAZY PRIMER
2
Cleared 510(K)
K
14
1839
PREMIER ETCH
2
Cleared 510(K)
K
14
0537
TENURE4G
2
Cleared 510(K)
K
14
1610
FUTURABOND M+
2
Cleared 510(K)
K
13
1734
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
2
Cleared 510(K)
K
13
3318
ADHESE UNIVERSAL
2
Cleared 510(K)
K
13
2923
FUSION SINGLE LINK
2
Cleared 510(K)
K
13
3078
K-ETCHANT SYRINGE; NEEDLE TIP (E)
2
Cleared 510(K)
K
13
2450
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
2
Cleared 510(K)
K
13
1043
APEX UNIVERSAL ADHESIVE
2
Cleared 510(K)
K
13
1357
PEAK Z
2
Cleared 510(K)
K
13
1430
CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL
2
Cleared 510(K)
K
13
1049
ZRP
2
Cleared 510(K)
K
13
1212
PREMIER CERAMIC PRIMER
2
Cleared 510(K)
K
13
1432
CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL
2
Cleared 510(K)
K
13
1248
ETCH GEL
2
Cleared 510(K)
K
13
0486
FUTURABOND UNIVERSAL
2
Cleared 510(K)
K
12
2522
DENTOETCH QUICKBOND BOND ACTIVATOR
2
Cleared 510(K)
K
12
3278
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
2
Cleared 510(K)
K
12
3119
CERARESIN BOND
2
Cleared 510(K)
K
12
0620
CLEAN AND BOOST
2
Cleared 510(K)
K
12
0767
ES BOND
2
Cleared 510(K)
K
12
0213
ETCH-RITE SUPREME
2
Cleared 510(K)
K
11
2597
SEITY 37% PHOSPHORIC ACID ETCHANT GEL
2
Cleared 510(K)
K
11
2118
DREAMBOND
2
Cleared 510(K)
K
11
1975
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
2
Cleared 510(K)
K
11
1980
CLEARFIL TRI-S BOND PLUS
2
Cleared 510(K)
K
11
1876
Z BOND, PRELUDE ONE
2
Cleared 510(K)
K
11
0403
PROLINK ADHESIVES (PROLINK, PROLINK SE)
2
Cleared 510(K)
K
11
1431
B1P ADHESIVE
2
Cleared 510(K)
K
11
0302
ADHESIVE EXL-759
2
Cleared 510(K)
K
11
0252
BEAUTIBOND MULTI PR PLUS
2
Cleared 510(K)
K
11
0235
BEAUTIBOND MULTI
2
Cleared 510(K)
K
10
2254
DMP SINGLE BONDING
2
Cleared 510(K)
K
10
2844
ALL-BOUND 3
2
Cleared 510(K)
K
10
1485
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
2
Cleared 510(K)
K
10
1423
OPTIBOND XTR
2
Cleared 510(K)
K
10
0752
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
2
Cleared 510(K)
K
10
0347
OPTIBOND SE
2
Cleared 510(K)
K
09
3014
AMERICAN DENTAL PRODUCTS SE BONDEASY
2
Cleared 510(K)
K
09
3744
EXCITE F AND EXCITE DSC
2
Cleared 510(K)
K
09
2616
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
2
Cleared 510(K)
K
09
1705
PRIMER PLUS
2
Cleared 510(K)
K
09
1300
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
2
Cleared 510(K)
K
09
0941
ADHESE ONE F
2
Cleared 510(K)
K
09
0826
MONOBOND PLUS
2
Cleared 510(K)
K
09
0106
PRELUDE ONE
2
Cleared 510(K)
K
08
3652
IBOND TOTAL ETCH
2
Cleared 510(K)
K
08
2744
BEAUTIBOND
2
Cleared 510(K)
K
08
2753
FUTURABOND M/FUTURABOND M SINGLE DOSE
2
Cleared 510(K)
K
08
2768
G-BOND PLUS
2
Cleared 510(K)
K
07
2480
GENERATION 8 SE ADHESIVE
2
Cleared 510(K)
K
07
1688
RELIANCE S.E.P.
2
Cleared 510(K)
K
07
1500
NANO-BOND II ADHESIVE SYSTEM
2
Cleared 510(K)
K
07
1131
UNO
2
Cleared 510(K)
K
07
1260
HERMES BOND 3
2
Cleared 510(K)
K
07
1452
FL BOND II
2
Cleared 510(K)
K
07
0723
FUTURABOND DC/SINGLE DOSE
2
Cleared 510(K)
K
07
0956
SEA2 SELF ETCH ADHESIVE
2
Cleared 510(K)
K
07
0646
ADHESE ONE
2
Cleared 510(K)
K
07
0413
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
2
Cleared 510(K)
K
07
0215
TOKUYAMA BOND FORCE
2
Cleared 510(K)
K
06
3444
TOTAL ETCH BONDING AGENT
2
Cleared 510(K)
K
07
0538
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
2
Cleared 510(K)
K
06
3780
ACE BOND SE
2
Cleared 510(K)
K
06
3558
PEAK SE, MODEL 5135
2
Cleared 510(K)
K
06
3557
PEAK BOND, MODEL 5133
2
Cleared 510(K)
K
06
3062
HKBOND 2006
2
Cleared 510(K)
K
06
2713
ADHESIVE DC ACTIVATOR
2
Cleared 510(K)
K
06
1998
PREMIER SELF-ETCHING BOND ENHANCER
2
Cleared 510(K)
K
06
2382
CLEARFIL DC BOND
2
Cleared 510(K)
K
06
1611
BOSWORTH DENTIN RESIN
2
Cleared 510(K)
K
06
0882
EXCEL BOND DC, MODEL 28-200100
2
Cleared 510(K)
K
06
1981
SURPASS
2
Cleared 510(K)
K
06
1322
PORCELAIN PRIMER
2
Cleared 510(K)
K
06
0684
ADPER PROMPT, ADPER PROMPT L-POP
2
Cleared 510(K)
K
06
0469
OPTIBOND ALL-IN-ONE
2
Cleared 510(K)
K
05
3103
INTERFACE
2
Cleared 510(K)
K
05
3392
FUTURABOND NR SINGLE DOSE
2
Cleared 510(K)
K
05
2699
VERSA-LINK PORCELAIN BONDING SYSTEM
2
Cleared 510(K)
K
05
2501
MULTIPLE RESIN TOOTH BONDING AGENT
2
Cleared 510(K)
K
05
2189
REVENEER CERAMIC REPAIR SYSTEM
2
Cleared 510(K)
K
05
1796
CLEARFIL TRI-S BOND SINGLE DOSE
2
Cleared 510(K)
K
05
1707
ECLIPSE BONDING AGENT
2
Cleared 510(K)
K
05
1463
XENO ADHESIVE WITH ACTIVATOR
2
Cleared 510(K)
K
05
1050
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
2
Cleared 510(K)
K
05
1006
IBOND NEXT GENERATION
2
Cleared 510(K)
K
05
0647
ALL-IN-ONE
2
Cleared 510(K)
K
05
0331
ADHESIVE 1
2
Cleared 510(K)
K
04
3170
BOSWORTH BOND
2
Cleared 510(K)
K
05
0386
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
2
Cleared 510(K)
K
04
3043
HERMES BOND 2
2
Cleared 510(K)
K
04
3562
BC PLUS
2
Cleared 510(K)
K
04
2913
CLEARFIL TRI-S BOND
2
Cleared 510(K)
K
04
2806
QUADRANT UNIT-1-BOND
2
Cleared 510(K)
K
04
2614
S&C-SELF ETCH PR-BOND
2
Cleared 510(K)
K
04
1680
ORAJEL ADVANCED TOOTH DESENSITIZER
2
Cleared 510(K)
K
04
2670
FUTURABOND NR
2
Cleared 510(K)
K
04
0079
M.L. PRIMER
2
Cleared 510(K)
K
04
1960
COMPOSITE/COMPOMER REPAIR KIT
2
Cleared 510(K)
K
04
1471
G-BOND
2
Cleared 510(K)
K
04
0952
PRELUDE
2
Cleared 510(K)
K
04
1343
XENO NM LIGHT CURED DENTAL ADHESIVE
2
Cleared 510(K)
K
04
0857
MODIFICATION TO ADPER PROMPT
2
Cleared 510(K)
K
03
3974
HERMES BOND
2
Cleared 510(K)
K
03
3938
CLEARFIL PROTECT BOND
2
Cleared 510(K)
K
03
3760
ONE COAT SE BOND
2
Cleared 510(K)
K
03
2953
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
2
Cleared 510(K)
K
03
2626
PERMAQUICK SE BONDING SYSTEM
2
Cleared 510(K)
K
03
2179
COMP. E
2
Cleared 510(K)
K
03
1915
PULPDENT ETCH-RITE ROYALE
2
Cleared 510(K)
K
03
1444
OPTIBOND FL
2
Cleared 510(K)
K
03
0844
FINAL VARNISH LC
2
Cleared 510(K)
K
03
0743
ETCHANT 40%
2
Cleared 510(K)
K
02
4356
CLEARFIL SILANE KIT
2
Cleared 510(K)
K
02
3842
CLEARFIL SE BOND PLUS
2
Cleared 510(K)
K
02
3776
XENO III DENTAL ADHESIVE
2
Cleared 510(K)
K
02
2973
ADHESIVE 14
2
Cleared 510(K)
K
02
3042
PQ1
2
Cleared 510(K)
K
02
2612
IBOND GLUMA INSIDE
2
Cleared 510(K)
K
02
1427
CLEARFIL SA PRIMER
2
Cleared 510(K)
K
02
0514
PULPDENT GLAZE II
2
Cleared 510(K)
K
02
0570
SIMPLICITY
2
Cleared 510(K)
K
02
0499
BOND-3 ADHESIVE
2
Cleared 510(K)
K
02
0303
XR PRIMER 2
2
Cleared 510(K)
K
02
0946
ADPER PROMPT
2
Cleared 510(K)
K
02
0239
TOUCH&BOND-PLUS
2
Cleared 510(K)
K
01
4027
OPTIBOND SOLO PLUS 4
2
Cleared 510(K)
K
01
3543
BOND-1 C & B
2
Cleared 510(K)
K
01
3997
UNIFIL BOND
2
Cleared 510(K)
K
02
0050
ENAMEL BONDING SYSTEM
2
Cleared 510(K)
K
01
3542
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
2
Cleared 510(K)
K
01
3584
EXCITE SELF ETCH
2
Cleared 510(K)
K
01
3519
SIMPLE
2
Cleared 510(K)
K
01
2082
OPTIBOND SOLO PLUS ACTIVATOR
2
Cleared 510(K)
K
01
2734
CLEARFIL NEW BOND
2
Cleared 510(K)
K
01
2730
CLEARFIL PORCELAIN BOND ACTIVATOR
2
Cleared 510(K)
K
01
2729
CLEARFIL REPAIR
2
Cleared 510(K)
K
01
2442
MODIFICATION TO CLEARFIL SE BOND
2
Cleared 510(K)
K
01
2440
MODIFICATION TO CLEARFIL LINER BOND 2V
2
Cleared 510(K)
K
01
2436
MODIFICATION TO ALLOY PRIMER
2
Cleared 510(K)
K
01
2432
MODIFICATION TO CLEARFIL PHOTO BOND
2
Cleared 510(K)
K
01
2322
OPTIBOND 2
2
Cleared 510(K)
K
01
0547
VERTEX SEALAND L/C ORTHODONTIC SEALANT
2
Cleared 510(K)
K
01
0415
ISODAN
2
Cleared 510(K)
K
01
1490
MODIFICATION TO EXCITE
2
Cleared 510(K)
K
01
1167
XSE
2
Cleared 510(K)
K
00
3293
EXCITE DSC
2
Cleared 510(K)
K
00
3011
SELF ETCH BONDING PRIMER
2
Cleared 510(K)
K
00
3153
SOLOBOND PLUS
2
Cleared 510(K)
K
00
2502
CERAM-PRIME
2
Cleared 510(K)
K
00
1914
CLEARFIL REPAIR
2
Cleared 510(K)
K
00
1494
MODIFICATION TO PROMPT L-POP
2
Cleared 510(K)
K
00
0189
PQ1
2
Cleared 510(K)
K
00
0954
KERR GEL ETCHANT
2
Cleared 510(K)
K
99
4359
BOND 1 C & B
2
Cleared 510(K)
K
99
4302
RESIN TOOTH BONDING AGENT
2
Cleared 510(K)
K
99
3917
TOKUYAMA ONE-UP-BOND F
2
Cleared 510(K)
K
99
3683
PULPDENT UNO-DUO
2
Cleared 510(K)
K
99
3013
SURE BOND
2
Cleared 510(K)
K
99
2838
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
2
Cleared 510(K)
K
99
2879
ECUSIT COMPOSITE REPAIR
2
Cleared 510(K)
K
99
2985
GLUMA COMFORT BOND
2
Cleared 510(K)
K
99
2292
GLUMA COMFORT BOND + DESENSITIZER
2
Cleared 510(K)
K
99
2048
MODIFICATION OF PROMPT L-POP
2
Cleared 510(K)
K
99
1808
OPTIBOND SOLO PLUS 2
2
Cleared 510(K)
K
99
0534
EXCITE
2
Cleared 510(K)
K
99
0498
OPTIBOND SOLO PLUS
2
Cleared 510(K)
K
98
4503
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
2
Cleared 510(K)
K
99
0143
GLUMA ONE BOND
2
Cleared 510(K)
K
99
0040
CLEARFIL SE BOND
2
Cleared 510(K)
K
98
4246
PROMPT L-POP
2
Cleared 510(K)
K
98
3414
EVERBOND
2
Cleared 510(K)
K
98
3668
MODIFICATION OF PQ1
2
Cleared 510(K)
K
98
3545
QUADRANT UNIBOND
2
Cleared 510(K)
K
98
2394
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
2
Cleared 510(K)
K
98
2007
TRUBYTE DENTURE BOND DENTURE BONDING AGENT
2
Cleared 510(K)
K
98
1514
GC FUJI BOND LC
2
Cleared 510(K)
K
98
1383
ALLOYBOND
2
Cleared 510(K)
K
97
4906
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
2
Cleared 510(K)
K
98
0539
SOLOBOND M
2
Cleared 510(K)
K
97
3002
HURRISEAL DENTIN DESENSITIZER
2
Cleared 510(K)
K
97
4786
PREPQUICK
2
Cleared 510(K)
K
97
3285
D/SENSE-T
2
Cleared 510(K)
K
97
4390
GLUMA ONE BOND
2
Cleared 510(K)
K
97
4486
CLEARFIL LINER BOND 2V
2
Cleared 510(K)
K
97
4283
PQ 1
2
Cleared 510(K)
K
97
4089
ALLOY PRIMER
2
Cleared 510(K)
K
97
3092
STAE
2
Cleared 510(K)
K
97
3185
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
2
Cleared 510(K)
K
97
3245
TOKUSO REBASE MR. BOND
2
Cleared 510(K)
K
97
1733
2 BOND 2
2
Cleared 510(K)
K
97
2101
SOLITAIRE
2
Cleared 510(K)
K
97
2858
KERR NEXUS ONE BOTTLE ADHESIVE
2
Cleared 510(K)
K
97
3388
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
2
Cleared 510(K)
K
97
2421
EASY BOND
2
Cleared 510(K)
K
97
2594
METALPRIMER II
2
Cleared 510(K)
K
97
1121
ENCORE BOND
2
Cleared 510(K)
K
97
0848
SILOC SYSTEM
2
Cleared 510(K)
K
96
4867
HYBRID RESIN COMPOSITE
2
Cleared 510(K)
K
96
4038
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
2
Cleared 510(K)
K
96
5138
DENTINSENSE B/C
2
Cleared 510(K)
K
96
4735
DENTINSENSE
2
Cleared 510(K)
K
96
4525
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
2
Cleared 510(K)
K
96
4133
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
2
Cleared 510(K)
K
96
4140
GLUMA CONDITIONER
2
Cleared 510(K)
K
96
4000
BISFIL 2B
2
Cleared 510(K)
K
96
2812
GLUMA DESENSITIZER/GLUMA 3 PRIMER
2
Cleared 510(K)
K
96
2428
EBS (ESPE BONDING SYSTEM)
2
Cleared 510(K)
K
96
2785
3M DENT SYSTEM
2
Cleared 510(K)
K
96
2515
KERR ADVANCED ADHESIVE
2
Cleared 510(K)
K
96
2348
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
2
Cleared 510(K)
K
96
0696
PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
2
Cleared 510(K)
K
96
2277
SELF CURE BONDING AGENT
2
Cleared 510(K)
K
96
1822
WET-PREP
2
Cleared 510(K)
K
96
0697
ULTRACID AND ULTRACID F DISINFECTING SOLUTION
2
Cleared 510(K)
K
96
0823
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
2
Cleared 510(K)
K
96
0365
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
2
Cleared 510(K)
K
95
5328
CONFI-BOND
2
Cleared 510(K)
K
96
0879
AMALGAMIBOND PLUS
2
Cleared 510(K)
K
95
5740
GLUFLORMA
2
Cleared 510(K)
K
95
5279
D-SENSE
2
Cleared 510(K)
K
95
4708
SILANE PRIMER
2
Cleared 510(K)
K
95
4133
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
2
Cleared 510(K)
K
95
3612
IMPERVA FLUOROBOND
2
Cleared 510(K)
K
95
3613
IMPERVA ENSURABOND
2
Cleared 510(K)
K
95
3504
MICROPRIME
2
Cleared 510(K)
K
95
3405
HEMA-BENZ
2
Cleared 510(K)
K
95
3166
FUJI BOND LC
2
Cleared 510(K)
K
95
3476
MULTI-PRIME AKA/MONO-PRIME
2
Cleared 510(K)
K
95
3859
BOND-IT DUAL CURE ACTIVATOR
2
Cleared 510(K)
K
95
3592
REVOLUTION BOND
2
Cleared 510(K)
K
95
3527
PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS
2
Cleared 510(K)
K
95
2124
ABOND
2
Cleared 510(K)
K
95
2123
MS EMULSION
2
Cleared 510(K)
K
95
1867
PERMAQUIK BONDING PRIMER
2
Cleared 510(K)
K
95
1864
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
2
Cleared 510(K)
K
95
1583
PERMAQUIK BONDING PRIMER
2
Cleared 510(K)
K
95
1220
HEMA-GLU
2
Cleared 510(K)
K
95
0905
C&B-METABOND RADIOPAQUE POWDER
2
Cleared 510(K)
K
95
0860
PERMALUTE
2
Cleared 510(K)
K
94
5604
ECLIPTOMER
2
Cleared 510(K)
K
94
5112
PULPDENT DUAL CURE UNFILLED BONDING RESIN
2
Cleared 510(K)
K
93
3360
GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER
2
Cleared 510(K)
K
94
3738
OPTIBOND-D
2
Cleared 510(K)
K
94
3373
PERMAGEN F/DC
2
Cleared 510(K)
K
94
3165
CLEARFIL PHOTO BOND
2
Cleared 510(K)
K
94
3170
CLEARFIL LINER BOND 2
2
Cleared 510(K)
K
94
3167
CLEARFIL NEW BOND
2
Cleared 510(K)
K
94
3166
CLEARFIL LINER BOND SYSTEM
2
Cleared 510(K)
K
94
2017
V-PRIMER
2
Cleared 510(K)
K
94
2493
SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM
2
Cleared 510(K)
K
94
1572
FLUORIDE-PSA PRIME/ADHESIVE
2
Cleared 510(K)
K
94
0513
OPTIBOND
2
Cleared 510(K)
K
93
6222
DENTIN CONDITIONING AND ADHESIVE SYSTEM
2
Cleared 510(K)
K
93
5961
GC FUJI COAT LC
2
Cleared 510(K)
K
93
5735
ATTACHMENT BOND
2
Cleared 510(K)
K
93
6100
CLEARFIL LINER BOND 2
2
Cleared 510(K)
K
93
4596
BISCO DUO LINK D/C LUTING COMPOSITE
2
Cleared 510(K)
K
93
4690
KERR OPTIBOND, MODIFICATION
2
Cleared 510(K)
K
93
1710
PULPDENT DENTAL BOND ENHANCER 2-B
2
Cleared 510(K)
K
93
2379
ALL-BOND(R) JR.
2
Cleared 510(K)
K
93
1870
BONDING RESIN PRODUCT LINE
2
Cleared 510(K)
K
93
1838
DENTHESIVE II
2
Cleared 510(K)
K
93
1812
NEW DENTINE ADHESIVE
2
Cleared 510(K)
K
93
0504
NEW DENTIN PRIMER
2
Cleared 510(K)
K
93
0989
PULPDENT UNFILLED DUAL CURE BONDING RESIN
2
Cleared 510(K)
K
92
4378
RESTOBOND 4
2
Cleared 510(K)
K
91
3581
WILDE ADHESIVE BONDING SYSTEM
2
Cleared 510(K)
K
92
5404
CLEARFIL PORCELAIN BOND ACTIVATOR
2
Cleared 510(K)
K
92
4670
DENTIN RELIEF
2
Cleared 510(K)
K
92
4181
POLIBOND
2
Cleared 510(K)
K
92
3842
BISCO UNIVERSAL BOND-3
2
Cleared 510(K)
K
92
3546
OPTIBOND
2
Cleared 510(K)
K
92
2615
COLTENE A.R.T. BOND
2
Cleared 510(K)
K
92
1701
DURAFILL BOND
2
Cleared 510(K)
K
92
0424
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
2
Cleared 510(K)
K
91
5511
MIRAGE COMPLETE KIT AND MIRAGE ABC KIT
2
Cleared 510(K)
K
91
5830
PRISMA UNIVERSAL BOND(R) 3
2
Cleared 510(K)
K
91
0069
SR-ISOSIT SPECTRA LINK SYSTEM
2
Cleared 510(K)
K
91
3965
ESPE(R) -SIL
2
Cleared 510(K)
K
91
3946
IMPERVA DUAL
2
Cleared 510(K)
K
91
1282
PULPDENT ENAMEL BONDING AGENT
2
Cleared 510(K)
K
91
2707
CLEARFIL LINER BOND SYSTEM
2
Cleared 510(K)
K
91
2256
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
2
Cleared 510(K)
K
91
1525
TOKUSO LIGHT BOND
2
Cleared 510(K)
K
91
0860
ALL-BOND 2
2
Cleared 510(K)
K
91
0628
ALL BOND LINER-F
2
Cleared 510(K)
K
90
5302
DENTHESIVE
2
Cleared 510(K)
K
90
4724
CONQUEST DIRECT FILLING COMPOSITE (DFC)
2
Cleared 510(K)
K
90
4289
PERTAC UNIVERSAL BOND
2
Cleared 510(K)
K
90
2744
DEGUFILL (TM) BOND
2
Cleared 510(K)
K
90
1870
DEGUFILL (R) BOND
2
Cleared 510(K)
K
90
1871
DEGUFILL (R) ADHESIVE
2
Cleared 510(K)
K
90
1913
SYNTAC (DENTIN BONDING AGENT)
2
Cleared 510(K)
K
89
7009
PALFIQUE LIGHT BONDING AGENT
2
Cleared 510(K)
K
90
0558
PERTAC BOND
2
Cleared 510(K)
K
89
7020
ALL-BOND DENTIN BONDING SYSTEM
2
Cleared 510(K)
K
89
6659
SILANE
2
Cleared 510(K)
K
89
6655
9.6% HYDROFLUORIC ACID GEL
2
Cleared 510(K)
K
89
6382
MODIFIED GLUMA BONDING SYSTEM
2
Cleared 510(K)
K
89
5750
HEMA-PRIMER
2
Cleared 510(K)
K
89
4315
RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
2
Cleared 510(K)
K
89
4994
DENTIN BONDING SYSTEM
2
Cleared 510(K)
K
89
4391
PVS DUAL CURE VENEER BONDING KIT
2
Cleared 510(K)
K
89
2003
ABRAKADABRA - DENTAL ADHESIVE SYSTEM
2
Cleared 510(K)
K
89
1455
DENTIN PRIMER
2
Cleared 510(K)
K
88
4533
SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
2
Cleared 510(K)
K
88
5010
TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
2
Cleared 510(K)
K
88
4918
PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER
2
Cleared 510(K)
K
88
4752
KETAC-GLAZE
2
Cleared 510(K)
K
88
4137
MIRAGE BOND
2
Cleared 510(K)
K
88
0684
XR PRIMER
2
Cleared 510(K)
K
87
4074
TEMPORARY DISCLOSING SOLUTION
2
Cleared 510(K)
K
87
2959
CLEARFIL PHOTO BOND
2
Cleared 510(K)
K
87
1636
CLEARFIL PORCELAIN BOND
2
Cleared 510(K)
K
86
3522
MODIFIED SELF-CURE BONDING AGENT
2
Cleared 510(K)
K
86
2829
PANAGRAF
2
Cleared 510(K)
K
86
0971
DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)
2
Cleared 510(K)
K
86
0346
KERR PORCELITE
2
Cleared 510(K)
K
85
2660
ETCH AND BOND
2
Cleared 510(K)
K
85
1056
OPAQUER/BONDING AGENT
2
Cleared 510(K)
K
84
3023
KERR PORCELAIN REPAIR PRIMER
2
Cleared 510(K)
K
84
3025
COMMAND ENAMEL-DENT DENTAL ADHESIVE
2
Cleared 510(K)
K
84
2078
JOHNSON & JOHNSON FLAVORED ETCHING GEL
2
Cleared 510(K)
K
84
0726
RESTODENT DENTIN BONDING AGENT
2
Cleared 510(K)
K
84
1458
NUMBER 20 R/L SYSTEM
2
Cleared 510(K)
K
84
1457
NUMBER 21 R/R SYSTEM
2
Cleared 510(K)
K
83
3718
ETCHING GEL
2
Cleared 510(K)
K
83
3473
DENTIN BONDING AGENT
2
Cleared 510(K)
K
83
0387
MICRODAPT DENTAL RESTORATIVE BONDING
2
Cleared 510(K)
K
82
2451
AURAFILL* DENTAL RESTORATIVE BONDING AG.
2
Cleared 510(K)
K
81
3180
SCOTCHBOND DENTAL ADHESIVE
2
Cleared 510(K)
K
81
2117
PERMAGUM ADHESIVE
2
Cleared 510(K)
K
81
2116
PERMAGUM
2
Cleared 510(K)
K
81
0407
HYDROXYLATE ENAMEL BOND SYSTEM
2
Cleared 510(K)
K
81
0265
VISIO-BAND
2
Cleared 510(K)
K
80
2681
HELIOBOND
2
Cleared 510(K)
K
80
2333
INSTANT BRIDGE
2
Cleared 510(K)
K
80
1216
DEN-MAT DENTIN BONDING AGENT
2
Cleared 510(K)
K
80
1093
PRISMA-BOND
2
Cleared 510(K)
K
80
0390
ANT. & POST. RESTORATIVE POWDER LIQ.
2
Cleared 510(K)
K
80
0389
ANTERIOR & POST. RESTORATIVE PASTE SYS.
2
Cleared 510(K)
K
79
0833
VISIO-BOND
2
Cleared 510(K)
K
78
2080
VENEER SYSTEM, MOSTIQUE LAMINATE
2
Cleared 510(K)
K
77
1328
UVIOBOND
2
Cleared 510(K)
K
77
1325
NIMETIC ETCHING GEL
2
Cleared 510(K)
K
77
1326
NIMETIC BONDING MATERIAL
2
Cleared 510(K)
K
76
0400
BONDING AGENT, VYTOL
2
Cleared 510(K)
K
76
0324
BONDING AGENT, PRESTIGE
2
Cleared 510(K)
KOL
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
1
Product Code
KOM
Adhesive, Denture, Acacia And Karaya With Sodium Borate
1
Product Code
KON
Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
3
Product Code
KOO
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
1
Product Code
KOP
Adhesive, Denture, Karaya
1
Product Code
KOQ
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
1
Product Code
KOR
Adhesive, Denture, Karaya With Sodium Borate
3
Product Code
KOS
Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
3
Product Code
KOT
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
1
Product Code
KXR
Applicator, Resin
1
Product Code
KXW
Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
1
Product Code
KXX
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
1
Product Code
KXY
Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
3
Product Code
KZN
Scanner, Color
2
Product Code
KZO
Ink, Arch Tracing
1
Product Code
KZP
Solution, Cement Dissolving
2
Product Code
LBH
Varnish, Cavity
2
Product Code
LPK
Bone Grafting Material, For Dental Bone Repair
2
Product Code
LYC
Bone Grafting Material, Synthetic
2
Product Code
LZD
Joint, Temporomandibular, Implant
3
Product Code
MMT
Resin, Root Canal Filling Containing Chloroform
3
Product Code
MMU
Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
3
Product Code
MPI
Glenoid Fossa Prosthesis
3
Product Code
MPJ
Interarticular Disc Prosthesis (Interpositional Implant)
3
Product Code
MPL
Mandibular Condyle Prosthesis
3
Product Code
MZW
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
2
Product Code
NDP
Accessories, Implant, Dental, Endosseous
1
Product Code
NFE
Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
2
Product Code
NHA
Abutment, Implant, Dental, Endosseous
2
Product Code
NKJ
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
1
Product Code
NME
Bur, Diamond Coated, Reprocessed
1
Product Code
NOF
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
2
Product Code
NPK
Barrier, Synthetic, Intraoral
2
Product Code
NPL
Barrier, Animal Source, Intraoral
2
Product Code
NPM
Bone Grafting Material, Animal Source
2
Product Code
NPZ
Bone Grafting Material, Dental, With Biologic Component
3
Product Code
NQA
Biologic Material, Dental
3
Product Code
NRQ
Blade-Form Endosseous Dental Implant
2
Product Code
NUN
Bone Grafting Material, Human Source
2
Product Code
NUX
Cleanser, Denture, Prescription
1
Product Code
NYD
Endodontic Kit
2
Product Code
OAT
Implant, Endosseous, Orthodontic
2
Product Code
NYE
Fixture Mount Kit
1
Product Code
OFW
Restorative Instrument And Component Tray
2
Product Code
OFY
Dental Implant Surgical Tray
1
Product Code
OIV
Dental Amalgam
2
Product Code
PHR
Diammine Silver Fluoride Dental Hypersensitivity Varnish
2
Product Code
PME
External Cleaning Solution
2
Product Code
PNP
Dental Abutment Design Software For Dental Laboratory
2
Product Code
POW
Crown And Bridge, Long-Term Temporary, Resin
2
Product Code
PZY
Additively Manufactured, Preformed, Resin Denture Tooth
2
Product Code
QJK
Intraoral Camera
2
Product Code
QRQ
Non-Irrigation Endosseous Dental Implant Drill Bits
1
Product Code
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Ear, Nose, Throat
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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subpart-d—prosthetic-devices
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KLE
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K101485
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ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101485
510(k) Type
Traditional
Applicant
BISCO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/26/2010
Days to Decision
90 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
DZS
Capsule, Dental, Amalgam
DYH
Adhesive, Bracket And Tooth Conditioner, Resin
DZE
Implant, Endosseous, Root-Form
EBC
Sealant, Pit And Fissure, And Conditioner
EBD
Coating, Filling Material, Resin
EBE
Coating, Denture Hydrophilic, Resin
EBF
Material, Tooth Shade, Resin
EBG
Crown And Bridge, Temporary, Resin
EBH
Material, Impression Tray, Resin
EBI
Resin, Denture, Relining, Repairing, Rebasing
EBL
Pin, Retentive And Splinting, And Accessory Instruments
EBO
Denture Repair Kit
EBP
Reliner, Denture, Over The Counter
EFD
Amalgamator, Dental, Ac-Powered
EFT
Cleanser, Denture, Over The Counter
EGG
Attachment, Precision, All
EHE
Dispenser, Mercury And/Or Alloy
EHO
Bar, Preformed
EHP
Clasp, Preformed
EHQ
Cusp, Preformed
EHR
Pad, Denture, Over The Counter
EHS
Cushion, Denture, Over The Counter
EIT
Applicator, Rapid Wax, Dental
EJH
Alloy, Metal, Base
EJJ
Alloy, Amalgam
EJK
Liner, Cavity, Calcium Hydroxide
EJL
Bur, Dental
EJP
Articulators
EJS
Alloy, Other Noble Metal
EJT
Alloy, Gold-Based Noble Metal
EJW
Clasp, Wire
EJX
Anchor, Preformed
EKL
Point, Silver, Endodontic
EKM
Gutta-Percha
EKN
Point, Paper, Endodontic
EKO
Denture Preformed (Partially Prefabricated Denture)
ELE
Implant, Subperiosteal
ELJ
Teeth, Artificial, Posterior With Metal Insert
ELK
Teeth, Artificial, Backing And Facing
ELL
Teeth, Porcelain
ELM
Denture, Plastic, Teeth
ELN
Teeth, Preformed Gold Denture
ELO
Cusp, Gold And Stainless Steel
ELR
Post, Root Canal
ELS
Splint, Endodontic Stabilizing
ELW
Material, Impression
ELY
Mercury
ELZ
Crown, Preformed
EMA
Cement, Dental
EMB
Zinc Oxide Eugenol
JER
Cleaner, Denture, Mechanical
KCR
Facebow
KCS
Pantograph
KIF
Resin, Root Canal Filling
KLE
Agent, Tooth Bonding, Resin
K
24
2749
TopCEM Ceramic Primer Ceramic Coupling Agent
K
24
2675
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
K
24
0153
Ceramic Etchant (HF-5 and HF-9)
K
24
1445
K-Bond Universal
K
24
1056
Light Cure Adhesive
K
24
0743
Peak Universal Bond
K
23
1039
CLEARFIL Universal Bond Quick 2
K
23
2978
DX. Bond V Dental Bonding Adhesive
K
23
1696
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
K
23
0465
Hi-Bond Universal
K
23
0009
EZ Bond Universal
K
22
2830
Rainbow 360
K
22
1450
Phosphoric Acid Etching Gel
K
22
2357
DenMat Glutaraldehyde Desensitizer
K
22
1033
UniPrime A, UniPrime E, UniPrime E/C
K
22
0804
Dia-X Bond Universal
K
21
0804
Adhese Universal DC, Cention Primer
K
21
3965
BeautiBond Xtreme
K
21
3401
DIAPLUS Universal
K
21
3093
STEP-1 PumEtch
K
21
0186
PacBond One
K
21
0945
Ultra SEP
K
20
3760
Tokuyama Universal Bond II
K
19
2913
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
K
20
0153
Bright Bond Universal
K
20
0682
BZF-29
K
20
1787
Light Cure Dental Adhesive
K
20
0462
EtchPro Etching Gel
K
19
2392
DiaPlus
K
19
2273
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
K
18
3424
Ambar, Ambar APS, Ambar Universal APS
K
19
1656
Zipbond
K
19
2961
ADH19
K
19
1523
Visalys Restorative Primer
K
19
1524
Visalys Tooth Primer
K
18
3391
Novidia Universal Bond
K
18
0917
GC Acrylic Primer
K
18
2162
OptiBond eXTRa Universal
K
18
1910
BracePaste MTP Light Cure Primer
K
18
1476
Prime&Bond active Universal Adhesive
K
18
0803
BeautiBond Universal
K
18
0802
Meta P&Bond
K
17
2953
Acid Etchant
K
17
2977
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K
17
1226
TOKUYAMA UNIVERSAL BOND
K
17
2176
Parkell Universal Adhesive
K
17
2106
SHOFU MZ Primer Plus
K
16
1077
RnD TE and RnD SE
K
16
1891
HC Primer
K
16
1042
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
K
16
1051
All-Bond Universal w/BAC (not finalized)
K
15
2243
One Coat 7 Universal
K
15
2110
e-1 etchants
K
15
1619
Prime&Bond Elect Universal Dental Adhesive
K
15
1518
BRUSH&BOND PLUS
K
15
0703
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
K
15
0933
iBond Universal & iBond Ceramic Primer
K
15
0696
Jade 37% Phosphoric Acid Etchant Gel
K
14
3140
G-Premio BOND
K
15
0164
Monobond Etch & Prime
K
14
2848
EAZY PRIMER
K
14
1839
PREMIER ETCH
K
14
0537
TENURE4G
K
14
1610
FUTURABOND M+
K
13
1734
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K
13
3318
ADHESE UNIVERSAL
K
13
2923
FUSION SINGLE LINK
K
13
3078
K-ETCHANT SYRINGE; NEEDLE TIP (E)
K
13
2450
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
K
13
1043
APEX UNIVERSAL ADHESIVE
K
13
1357
PEAK Z
K
13
1430
CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL
K
13
1049
ZRP
K
13
1212
PREMIER CERAMIC PRIMER
K
13
1432
CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL
K
13
1248
ETCH GEL
K
13
0486
FUTURABOND UNIVERSAL
K
12
2522
DENTOETCH QUICKBOND BOND ACTIVATOR
K
12
3278
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
K
12
3119
CERARESIN BOND
K
12
0620
CLEAN AND BOOST
K
12
0767
ES BOND
K
12
0213
ETCH-RITE SUPREME
K
11
2597
SEITY 37% PHOSPHORIC ACID ETCHANT GEL
K
11
2118
DREAMBOND
K
11
1975
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
K
11
1980
CLEARFIL TRI-S BOND PLUS
K
11
1876
Z BOND, PRELUDE ONE
K
11
0403
PROLINK ADHESIVES (PROLINK, PROLINK SE)
K
11
1431
B1P ADHESIVE
K
11
0302
ADHESIVE EXL-759
K
11
0252
BEAUTIBOND MULTI PR PLUS
K
11
0235
BEAUTIBOND MULTI
K
10
2254
DMP SINGLE BONDING
K
10
2844
ALL-BOUND 3
K
10
1485
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
K
10
1423
OPTIBOND XTR
K
10
0752
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K
10
0347
OPTIBOND SE
K
09
3014
AMERICAN DENTAL PRODUCTS SE BONDEASY
K
09
3744
EXCITE F AND EXCITE DSC
K
09
2616
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
K
09
1705
PRIMER PLUS
K
09
1300
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
K
09
0941
ADHESE ONE F
K
09
0826
MONOBOND PLUS
K
09
0106
PRELUDE ONE
K
08
3652
IBOND TOTAL ETCH
K
08
2744
BEAUTIBOND
K
08
2753
FUTURABOND M/FUTURABOND M SINGLE DOSE
K
08
2768
G-BOND PLUS
K
07
2480
GENERATION 8 SE ADHESIVE
K
07
1688
RELIANCE S.E.P.
K
07
1500
NANO-BOND II ADHESIVE SYSTEM
K
07
1131
UNO
K
07
1260
HERMES BOND 3
K
07
1452
FL BOND II
K
07
0723
FUTURABOND DC/SINGLE DOSE
K
07
0956
SEA2 SELF ETCH ADHESIVE
K
07
0646
ADHESE ONE
K
07
0413
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
K
07
0215
TOKUYAMA BOND FORCE
K
06
3444
TOTAL ETCH BONDING AGENT
K
07
0538
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K
06
3780
ACE BOND SE
K
06
3558
PEAK SE, MODEL 5135
K
06
3557
PEAK BOND, MODEL 5133
K
06
3062
HKBOND 2006
K
06
2713
ADHESIVE DC ACTIVATOR
K
06
1998
PREMIER SELF-ETCHING BOND ENHANCER
K
06
2382
CLEARFIL DC BOND
K
06
1611
BOSWORTH DENTIN RESIN
K
06
0882
EXCEL BOND DC, MODEL 28-200100
K
06
1981
SURPASS
K
06
1322
PORCELAIN PRIMER
K
06
0684
ADPER PROMPT, ADPER PROMPT L-POP
K
06
0469
OPTIBOND ALL-IN-ONE
K
05
3103
INTERFACE
K
05
3392
FUTURABOND NR SINGLE DOSE
K
05
2699
VERSA-LINK PORCELAIN BONDING SYSTEM
K
05
2501
MULTIPLE RESIN TOOTH BONDING AGENT
K
05
2189
REVENEER CERAMIC REPAIR SYSTEM
K
05
1796
CLEARFIL TRI-S BOND SINGLE DOSE
K
05
1707
ECLIPSE BONDING AGENT
K
05
1463
XENO ADHESIVE WITH ACTIVATOR
K
05
1050
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
K
05
1006
IBOND NEXT GENERATION
K
05
0647
ALL-IN-ONE
K
05
0331
ADHESIVE 1
K
04
3170
BOSWORTH BOND
K
05
0386
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
K
04
3043
HERMES BOND 2
K
04
3562
BC PLUS
K
04
2913
CLEARFIL TRI-S BOND
K
04
2806
QUADRANT UNIT-1-BOND
K
04
2614
S&C-SELF ETCH PR-BOND
K
04
1680
ORAJEL ADVANCED TOOTH DESENSITIZER
K
04
2670
FUTURABOND NR
K
04
0079
M.L. PRIMER
K
04
1960
COMPOSITE/COMPOMER REPAIR KIT
K
04
1471
G-BOND
K
04
0952
PRELUDE
K
04
1343
XENO NM LIGHT CURED DENTAL ADHESIVE
K
04
0857
MODIFICATION TO ADPER PROMPT
K
03
3974
HERMES BOND
K
03
3938
CLEARFIL PROTECT BOND
K
03
3760
ONE COAT SE BOND
K
03
2953
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
K
03
2626
PERMAQUICK SE BONDING SYSTEM
K
03
2179
COMP. E
K
03
1915
PULPDENT ETCH-RITE ROYALE
K
03
1444
OPTIBOND FL
K
03
0844
FINAL VARNISH LC
K
03
0743
ETCHANT 40%
K
02
4356
CLEARFIL SILANE KIT
K
02
3842
CLEARFIL SE BOND PLUS
K
02
3776
XENO III DENTAL ADHESIVE
K
02
2973
ADHESIVE 14
K
02
3042
PQ1
K
02
2612
IBOND GLUMA INSIDE
K
02
1427
CLEARFIL SA PRIMER
K
02
0514
PULPDENT GLAZE II
K
02
0570
SIMPLICITY
K
02
0499
BOND-3 ADHESIVE
K
02
0303
XR PRIMER 2
K
02
0946
ADPER PROMPT
K
02
0239
TOUCH&BOND-PLUS
K
01
4027
OPTIBOND SOLO PLUS 4
K
01
3543
BOND-1 C & B
K
01
3997
UNIFIL BOND
K
02
0050
ENAMEL BONDING SYSTEM
K
01
3542
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
K
01
3584
EXCITE SELF ETCH
K
01
3519
SIMPLE
K
01
2082
OPTIBOND SOLO PLUS ACTIVATOR
K
01
2734
CLEARFIL NEW BOND
K
01
2730
CLEARFIL PORCELAIN BOND ACTIVATOR
K
01
2729
CLEARFIL REPAIR
K
01
2442
MODIFICATION TO CLEARFIL SE BOND
K
01
2440
MODIFICATION TO CLEARFIL LINER BOND 2V
K
01
2436
MODIFICATION TO ALLOY PRIMER
K
01
2432
MODIFICATION TO CLEARFIL PHOTO BOND
K
01
2322
OPTIBOND 2
K
01
0547
VERTEX SEALAND L/C ORTHODONTIC SEALANT
K
01
0415
ISODAN
K
01
1490
MODIFICATION TO EXCITE
K
01
1167
XSE
K
00
3293
EXCITE DSC
K
00
3011
SELF ETCH BONDING PRIMER
K
00
3153
SOLOBOND PLUS
K
00
2502
CERAM-PRIME
K
00
1914
CLEARFIL REPAIR
K
00
1494
MODIFICATION TO PROMPT L-POP
K
00
0189
PQ1
K
00
0954
KERR GEL ETCHANT
K
99
4359
BOND 1 C & B
K
99
4302
RESIN TOOTH BONDING AGENT
K
99
3917
TOKUYAMA ONE-UP-BOND F
K
99
3683
PULPDENT UNO-DUO
K
99
3013
SURE BOND
K
99
2838
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
K
99
2879
ECUSIT COMPOSITE REPAIR
K
99
2985
GLUMA COMFORT BOND
K
99
2292
GLUMA COMFORT BOND + DESENSITIZER
K
99
2048
MODIFICATION OF PROMPT L-POP
K
99
1808
OPTIBOND SOLO PLUS 2
K
99
0534
EXCITE
K
99
0498
OPTIBOND SOLO PLUS
K
98
4503
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
K
99
0143
GLUMA ONE BOND
K
99
0040
CLEARFIL SE BOND
K
98
4246
PROMPT L-POP
K
98
3414
EVERBOND
K
98
3668
MODIFICATION OF PQ1
K
98
3545
QUADRANT UNIBOND
K
98
2394
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K
98
2007
TRUBYTE DENTURE BOND DENTURE BONDING AGENT
K
98
1514
GC FUJI BOND LC
K
98
1383
ALLOYBOND
K
97
4906
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
K
98
0539
SOLOBOND M
K
97
3002
HURRISEAL DENTIN DESENSITIZER
K
97
4786
PREPQUICK
K
97
3285
D/SENSE-T
K
97
4390
GLUMA ONE BOND
K
97
4486
CLEARFIL LINER BOND 2V
K
97
4283
PQ 1
K
97
4089
ALLOY PRIMER
K
97
3092
STAE
K
97
3185
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
K
97
3245
TOKUSO REBASE MR. BOND
K
97
1733
2 BOND 2
K
97
2101
SOLITAIRE
K
97
2858
KERR NEXUS ONE BOTTLE ADHESIVE
K
97
3388
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
K
97
2421
EASY BOND
K
97
2594
METALPRIMER II
K
97
1121
ENCORE BOND
K
97
0848
SILOC SYSTEM
K
96
4867
HYBRID RESIN COMPOSITE
K
96
4038
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
K
96
5138
DENTINSENSE B/C
K
96
4735
DENTINSENSE
K
96
4525
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
K
96
4133
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
K
96
4140
GLUMA CONDITIONER
K
96
4000
BISFIL 2B
K
96
2812
GLUMA DESENSITIZER/GLUMA 3 PRIMER
K
96
2428
EBS (ESPE BONDING SYSTEM)
K
96
2785
3M DENT SYSTEM
K
96
2515
KERR ADVANCED ADHESIVE
K
96
2348
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K
96
0696
PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
K
96
2277
SELF CURE BONDING AGENT
K
96
1822
WET-PREP
K
96
0697
ULTRACID AND ULTRACID F DISINFECTING SOLUTION
K
96
0823
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K
96
0365
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
K
95
5328
CONFI-BOND
K
96
0879
AMALGAMIBOND PLUS
K
95
5740
GLUFLORMA
K
95
5279
D-SENSE
K
95
4708
SILANE PRIMER
K
95
4133
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
K
95
3612
IMPERVA FLUOROBOND
K
95
3613
IMPERVA ENSURABOND
K
95
3504
MICROPRIME
K
95
3405
HEMA-BENZ
K
95
3166
FUJI BOND LC
K
95
3476
MULTI-PRIME AKA/MONO-PRIME
K
95
3859
BOND-IT DUAL CURE ACTIVATOR
K
95
3592
REVOLUTION BOND
K
95
3527
PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS
K
95
2124
ABOND
K
95
2123
MS EMULSION
K
95
1867
PERMAQUIK BONDING PRIMER
K
95
1864
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
K
95
1583
PERMAQUIK BONDING PRIMER
K
95
1220
HEMA-GLU
K
95
0905
C&B-METABOND RADIOPAQUE POWDER
K
95
0860
PERMALUTE
K
94
5604
ECLIPTOMER
K
94
5112
PULPDENT DUAL CURE UNFILLED BONDING RESIN
K
93
3360
GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER
K
94
3738
OPTIBOND-D
K
94
3373
PERMAGEN F/DC
K
94
3165
CLEARFIL PHOTO BOND
K
94
3170
CLEARFIL LINER BOND 2
K
94
3167
CLEARFIL NEW BOND
K
94
3166
CLEARFIL LINER BOND SYSTEM
K
94
2017
V-PRIMER
K
94
2493
SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM
K
94
1572
FLUORIDE-PSA PRIME/ADHESIVE
K
94
0513
OPTIBOND
K
93
6222
DENTIN CONDITIONING AND ADHESIVE SYSTEM
K
93
5961
GC FUJI COAT LC
K
93
5735
ATTACHMENT BOND
K
93
6100
CLEARFIL LINER BOND 2
K
93
4596
BISCO DUO LINK D/C LUTING COMPOSITE
K
93
4690
KERR OPTIBOND, MODIFICATION
K
93
1710
PULPDENT DENTAL BOND ENHANCER 2-B
K
93
2379
ALL-BOND(R) JR.
K
93
1870
BONDING RESIN PRODUCT LINE
K
93
1838
DENTHESIVE II
K
93
1812
NEW DENTINE ADHESIVE
K
93
0504
NEW DENTIN PRIMER
K
93
0989
PULPDENT UNFILLED DUAL CURE BONDING RESIN
K
92
4378
RESTOBOND 4
K
91
3581
WILDE ADHESIVE BONDING SYSTEM
K
92
5404
CLEARFIL PORCELAIN BOND ACTIVATOR
K
92
4670
DENTIN RELIEF
K
92
4181
POLIBOND
K
92
3842
BISCO UNIVERSAL BOND-3
K
92
3546
OPTIBOND
K
92
2615
COLTENE A.R.T. BOND
K
92
1701
DURAFILL BOND
K
92
0424
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K
91
5511
MIRAGE COMPLETE KIT AND MIRAGE ABC KIT
K
91
5830
PRISMA UNIVERSAL BOND(R) 3
K
91
0069
SR-ISOSIT SPECTRA LINK SYSTEM
K
91
3965
ESPE(R) -SIL
K
91
3946
IMPERVA DUAL
K
91
1282
PULPDENT ENAMEL BONDING AGENT
K
91
2707
CLEARFIL LINER BOND SYSTEM
K
91
2256
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
K
91
1525
TOKUSO LIGHT BOND
K
91
0860
ALL-BOND 2
K
91
0628
ALL BOND LINER-F
K
90
5302
DENTHESIVE
K
90
4724
CONQUEST DIRECT FILLING COMPOSITE (DFC)
K
90
4289
PERTAC UNIVERSAL BOND
K
90
2744
DEGUFILL (TM) BOND
K
90
1870
DEGUFILL (R) BOND
K
90
1871
DEGUFILL (R) ADHESIVE
K
90
1913
SYNTAC (DENTIN BONDING AGENT)
K
89
7009
PALFIQUE LIGHT BONDING AGENT
K
90
0558
PERTAC BOND
K
89
7020
ALL-BOND DENTIN BONDING SYSTEM
K
89
6659
SILANE
K
89
6655
9.6% HYDROFLUORIC ACID GEL
K
89
6382
MODIFIED GLUMA BONDING SYSTEM
K
89
5750
HEMA-PRIMER
K
89
4315
RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
K
89
4994
DENTIN BONDING SYSTEM
K
89
4391
PVS DUAL CURE VENEER BONDING KIT
K
89
2003
ABRAKADABRA - DENTAL ADHESIVE SYSTEM
K
89
1455
DENTIN PRIMER
K
88
4533
SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
K
88
5010
TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
K
88
4918
PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER
K
88
4752
KETAC-GLAZE
K
88
4137
MIRAGE BOND
K
88
0684
XR PRIMER
K
87
4074
TEMPORARY DISCLOSING SOLUTION
K
87
2959
CLEARFIL PHOTO BOND
K
87
1636
CLEARFIL PORCELAIN BOND
K
86
3522
MODIFIED SELF-CURE BONDING AGENT
K
86
2829
PANAGRAF
K
86
0971
DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)
K
86
0346
KERR PORCELITE
K
85
2660
ETCH AND BOND
K
85
1056
OPAQUER/BONDING AGENT
K
84
3023
KERR PORCELAIN REPAIR PRIMER
K
84
3025
COMMAND ENAMEL-DENT DENTAL ADHESIVE
K
84
2078
JOHNSON & JOHNSON FLAVORED ETCHING GEL
K
84
0726
RESTODENT DENTIN BONDING AGENT
K
84
1458
NUMBER 20 R/L SYSTEM
K
84
1457
NUMBER 21 R/R SYSTEM
K
83
3718
ETCHING GEL
K
83
3473
DENTIN BONDING AGENT
K
83
0387
MICRODAPT DENTAL RESTORATIVE BONDING
K
82
2451
AURAFILL* DENTAL RESTORATIVE BONDING AG.
K
81
3180
SCOTCHBOND DENTAL ADHESIVE
K
81
2117
PERMAGUM ADHESIVE
K
81
2116
PERMAGUM
K
81
0407
HYDROXYLATE ENAMEL BOND SYSTEM
K
81
0265
VISIO-BAND
K
80
2681
HELIOBOND
K
80
2333
INSTANT BRIDGE
K
80
1216
DEN-MAT DENTIN BONDING AGENT
K
80
1093
PRISMA-BOND
K
80
0390
ANT. & POST. RESTORATIVE POWDER LIQ.
K
80
0389
ANTERIOR & POST. RESTORATIVE PASTE SYS.
K
79
0833
VISIO-BOND
K
78
2080
VENEER SYSTEM, MOSTIQUE LAMINATE
K
77
1328
UVIOBOND
K
77
1325
NIMETIC ETCHING GEL
K
77
1326
NIMETIC BONDING MATERIAL
K
76
0400
BONDING AGENT, VYTOL
K
76
0324
BONDING AGENT, PRESTIGE
KOL
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
KOM
Adhesive, Denture, Acacia And Karaya With Sodium Borate
KON
Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
KOO
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
KOP
Adhesive, Denture, Karaya
KOQ
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
KOR
Adhesive, Denture, Karaya With Sodium Borate
KOS
Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
KOT
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
KXR
Applicator, Resin
KXW
Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
KXX
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
KXY
Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
KZN
Scanner, Color
KZO
Ink, Arch Tracing
KZP
Solution, Cement Dissolving
LBH
Varnish, Cavity
LPK
Bone Grafting Material, For Dental Bone Repair
LYC
Bone Grafting Material, Synthetic
LZD
Joint, Temporomandibular, Implant
MMT
Resin, Root Canal Filling Containing Chloroform
MMU
Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
MPI
Glenoid Fossa Prosthesis
MPJ
Interarticular Disc Prosthesis (Interpositional Implant)
MPL
Mandibular Condyle Prosthesis
MZW
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
NDP
Accessories, Implant, Dental, Endosseous
NFE
Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
NHA
Abutment, Implant, Dental, Endosseous
NKJ
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
NME
Bur, Diamond Coated, Reprocessed
NOF
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
NPK
Barrier, Synthetic, Intraoral
NPL
Barrier, Animal Source, Intraoral
NPM
Bone Grafting Material, Animal Source
NPZ
Bone Grafting Material, Dental, With Biologic Component
NQA
Biologic Material, Dental
NRQ
Blade-Form Endosseous Dental Implant
NUN
Bone Grafting Material, Human Source
NUX
Cleanser, Denture, Prescription
NYD
Endodontic Kit
OAT
Implant, Endosseous, Orthodontic
NYE
Fixture Mount Kit
OFW
Restorative Instrument And Component Tray
OFY
Dental Implant Surgical Tray
OIV
Dental Amalgam
PHR
Diammine Silver Fluoride Dental Hypersensitivity Varnish
PME
External Cleaning Solution
PNP
Dental Abutment Design Software For Dental Laboratory
POW
Crown And Bridge, Long-Term Temporary, Resin
PZY
Additively Manufactured, Preformed, Resin Denture Tooth
QJK
Intraoral Camera
QRQ
Non-Irrigation Endosseous Dental Implant Drill Bits
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-d—prosthetic-devices
/
KLE
/
K101485
View Source
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101485
510(k) Type
Traditional
Applicant
BISCO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/26/2010
Days to Decision
90 days
Submission Type
Summary