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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Miscellaneous
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
K
25
0015
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
2
Cleared 510(K)
K
24
2537
BracePaste Fluoride Sealant
2
Cleared 510(K)
K
23
4043
3M™ Transbond™ Orthodontic Adhesive
2
Cleared 510(K)
K
23
1817
AlignerFlow LC
2
Cleared 510(K)
K
21
4054
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
2
Cleared 510(K)
K
21
0115
FiteBac CC OrthoSeal
2
Cleared 510(K)
K
20
2276
BracePaste Band and Build LC
2
Cleared 510(K)
K
19
2682
Orthocem, Ortho Bite
2
Cleared 510(K)
K
19
3388
GlassLok Kits, GlassLok Powder, GlassLok Liquid
2
Cleared 510(K)
K
18
3147
BrackFix
2
Cleared 510(K)
K
17
3020
OBA-MCP, Orthodontic Bracket Adhesive with MCP
2
Cleared 510(K)
K
16
0782
BracePaste Adhesive
2
Cleared 510(K)
K
16
1684
Quantum LB
2
Cleared 510(K)
K
15
0128
GC Ortho Connect, GC Ortho Etching Gel
2
Cleared 510(K)
K
14
3667
GC KommonBase
2
Cleared 510(K)
K
14
2886
DMRC Self-Cure Bracket Adhesive One Step and Primer
2
Cleared 510(K)
K
14
2881
DMRC Dual Cure Orthodontic Band Cement
2
Cleared 510(K)
K
14
2880
DMRC Light Cure Orthodontic Adhesive System
2
Cleared 510(K)
K
12
3348
CLEAR ALIGNER ADHESIVE
2
Cleared 510(K)
K
12
0619
ORTHODONTIC FLOWABLE BRACKET ADHESIVE
2
Cleared 510(K)
K
11
3401
ORTHO-1(NOT FINALIZED)
2
Cleared 510(K)
K
11
3197
APC FLASH-FREE ADHESIVE
2
Cleared 510(K)
K
11
1814
PADLOCK
2
Cleared 510(K)
K
11
1696
OPAL BAND CEMENT
2
Cleared 510(K)
K
10
1951
LIGHT CURE RETAINER
2
Cleared 510(K)
K
10
0536
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
2
Cleared 510(K)
K
10
0301
OPAL BOND FLOW
2
Cleared 510(K)
K
09
4006
OPAL BOND MV
2
Cleared 510(K)
K
09
3221
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
2
Cleared 510(K)
K
09
0355
OPAL SEAL
2
Cleared 510(K)
K
08
3051
FLOWTAIN & FLOWTAIN LV
2
Cleared 510(K)
K
08
0445
LION SE ONE STEP ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
08
0724
GC OPB-100
2
Cleared 510(K)
K
08
1291
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
2
Cleared 510(K)
K
07
3697
TRANSBOND SUPREME ADHESIVE
2
Cleared 510(K)
K
07
3588
GC MODELS OPA-100 AND JC-50
2
Cleared 510(K)
K
07
2978
TENDER ORTHO BOND-ENA BOND-ENA ETCH
2
Cleared 510(K)
K
07
2830
RM BOND, MODEL J032
2
Cleared 510(K)
K
07
1590
THERMA-CURE
2
Cleared 510(K)
K
06
1252
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
2
Cleared 510(K)
K
06
1481
GRENGLOO
2
Cleared 510(K)
K
05
3379
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
05
0750
LC BRACKET ADHESIVE SYSTEM
2
Cleared 510(K)
K
04
2422
D3 CHROMA
2
Cleared 510(K)
K
04
0375
IDEAL 1 ORTHODONTIC BAND CEMENT
2
Cleared 510(K)
K
04
0548
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
04
0547
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
03
3703
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
2
Cleared 510(K)
K
03
3551
EVOLVE
2
Cleared 510(K)
K
03
0644
CONTEC DUO, CONTEC LC, CONTEC LCR
2
Cleared 510(K)
K
03
2195
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
2
Cleared 510(K)
K
03
2407
OPTIBAND LC
2
Cleared 510(K)
K
03
2042
ENVISION
2
Cleared 510(K)
K
03
0980
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
2
Cleared 510(K)
K
03
0977
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
2
Cleared 510(K)
K
03
1420
S & C -BRACKET ADHESIVES
2
Cleared 510(K)
K
03
0036
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
2
Cleared 510(K)
K
02
2224
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
2
Cleared 510(K)
K
02
0648
GRIDLOCK 195 ADHESIVE
2
Cleared 510(K)
K
02
0502
SOLO ORTHO 3
2
Cleared 510(K)
K
02
0578
GC FUJI ORTHO BAND PASTE PAK
2
Cleared 510(K)
K
02
0394
APC PLUS ADHESIVE
2
Cleared 510(K)
K
01
4138
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
2
Cleared 510(K)
K
01
4133
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
2
Cleared 510(K)
K
02
0115
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
2
Cleared 510(K)
K
01
4142
UNITE BONDING ADHESIVE
2
Cleared 510(K)
K
01
4059
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
2
Cleared 510(K)
K
01
2673
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
2
Cleared 510(K)
K
01
2032
FIRST SPEP
2
Cleared 510(K)
K
01
0544
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
2
Cleared 510(K)
K
01
1521
ORTHO VLC; ORTHO VLC CAPSULE
2
Cleared 510(K)
K
00
1881
IMPROVED ENLIGHT LV
2
Cleared 510(K)
K
00
1446
LIGHT-CURED ORTHODONTIC BAND CEMENT
2
Cleared 510(K)
K
00
1048
LIGHT BOND (QUICK CURE)
2
Cleared 510(K)
K
99
4309
SOLO ORTHO 2
2
Cleared 510(K)
K
99
0743
SOLO ORTHO
2
Cleared 510(K)
K
98
1036
SMARTBOND
2
Cleared 510(K)
K
99
0252
SOLO PLUS ORTHO
2
Cleared 510(K)
K
98
4362
ENLIGHT LV
2
Cleared 510(K)
K
98
4217
ENLIGHT-2
2
Cleared 510(K)
K
98
1461
GC FUJI ORTHO LC
2
Cleared 510(K)
K
97
2890
ENLIGHT (TENTATIVE NAME)
2
Cleared 510(K)
K
96
2946
ORTHO-ONE
2
Cleared 510(K)
K
96
1417
GC FUJI ORTHO
2
Cleared 510(K)
K
95
5329
RESILIENCE M5 PROTECTION PLUS
2
Cleared 510(K)
K
95
4374
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
2
Cleared 510(K)
K
95
4373
AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
2
Cleared 510(K)
K
95
4372
AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
2
Cleared 510(K)
K
95
4333
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM
2
Cleared 510(K)
K
95
4244
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE
2
Cleared 510(K)
K
95
2856
LIGHT-CURE PC
2
Cleared 510(K)
K
95
2855
PC-LOCK
2
Cleared 510(K)
K
95
2858
LIGHT-CURE
2
Cleared 510(K)
K
95
2857
PRO-LOCK
2
Cleared 510(K)
K
95
3217
PULPDENT TOUCHDOWN
2
Cleared 510(K)
K
95
2854
PULPDENT GLASS IONOMER CEMENTS
2
Cleared 510(K)
K
95
2643
RIGHT-ON ADHESIVE BOUDING SYSTEM
2
Cleared 510(K)
K
95
1380
VILA PC
2
Cleared 510(K)
K
95
1381
VILA
2
Cleared 510(K)
K
95
1235
GIROC
2
Cleared 510(K)
K
95
1236
PRO-LOCK
2
Cleared 510(K)
K
95
0556
FUJI ORTHO LC
2
Cleared 510(K)
K
95
0512
AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
2
Cleared 510(K)
K
95
0514
TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
2
Cleared 510(K)
K
94
6255
THERMASET
2
Cleared 510(K)
K
94
2742
ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV
2
Cleared 510(K)
K
94
2727
ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE
2
Cleared 510(K)
K
93
5625
ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
2
Cleared 510(K)
K
94
1015
ORMCO SYSTEM 1+ (TM)
2
Cleared 510(K)
K
94
0845
SYSTEM 1
2
Cleared 510(K)
K
93
5714
CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE
2
Cleared 510(K)
K
92
5359
RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS
2
Cleared 510(K)
K
93
0614
ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST
2
Cleared 510(K)
K
92
1283
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
2
Cleared 510(K)
K
92
1044
ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND
2
Cleared 510(K)
K
92
3399
CHALLENGE II - PASTE ADHESIVE
2
Cleared 510(K)
K
92
1245
THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II
2
Cleared 510(K)
K
92
1385
IMPROVED SEQUENCE LIGHT CURE ADHESIVE
2
Cleared 510(K)
K
92
0781
FLASH BOND
2
Cleared 510(K)
K
92
0534
PORCELAIN PRIMER
2
Cleared 510(K)
K
91
4317
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
2
Cleared 510(K)
K
91
4727
SEQUENCE LIGHT CURE ADHESIVE
2
Cleared 510(K)
K
91
3854
ORTHO LIGHT CURE
2
Cleared 510(K)
K
91
1286
PULPDENT ORTHODONTIC BRACKET ADHESIVE
2
Cleared 510(K)
K
91
1271
ADHESIVE PRECOATED BRACKETS
2
Cleared 510(K)
K
90
4090
ORTHODONTIC BONDING ADHESIVE CONTROL
2
Cleared 510(K)
K
91
0803
ENAMEL ETCHING GEL
2
Cleared 510(K)
K
89
5523
PHASE II ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
89
5521
RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)
2
Cleared 510(K)
K
89
5522
LIGHT BOND PASTE W/FLUORIDE
2
Cleared 510(K)
K
89
5163
FORCE II
2
Cleared 510(K)
K
89
4639
SKYROCK AND LIGHT SUPERBOND
2
Cleared 510(K)
K
89
4565
LIGHT BOND SEALANT WITH FLUORIDE
2
Cleared 510(K)
K
89
4566
MAXIMUM CURE SEALANT WITH FLUORIDE
2
Cleared 510(K)
K
89
3396
AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
2
Cleared 510(K)
K
89
3255
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
89
3037
NO-MIX 30 ORTHODONTIC BONDING SYSTEMS
2
Cleared 510(K)
K
89
1464
RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4
2
Cleared 510(K)
K
89
0834
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
2
Cleared 510(K)
K
89
0740
FRS LITE FLUORIDE RELEASING SEALANT
2
Cleared 510(K)
K
88
4575
MAXIBOND
2
Cleared 510(K)
K
88
3465
ORTHO-SEAL
2
Cleared 510(K)
K
88
0562
ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT
2
Cleared 510(K)
K
88
0793
LIGHT BOND
2
Cleared 510(K)
K
88
0791
MAXIMUM CURE SEALANT
2
Cleared 510(K)
K
88
0766
RELIANCE METAL PRIMER
2
Cleared 510(K)
K
88
0792
PLASTIC PRIMER
2
Cleared 510(K)
K
88
0790
PORCELAIN PRIMER
2
Cleared 510(K)
K
88
0393
TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
87
4228
BOND FAST NO MIX ADHESIVE
2
Cleared 510(K)
K
87
5142
PHASE II
2
Cleared 510(K)
K
87
5144
EXCEL FAST SET
2
Cleared 510(K)
K
87
5141
EXCEL REGULAR SET
2
Cleared 510(K)
K
87
5143
RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
2
Cleared 510(K)
K
87
1591
ORMCO GEL-ETCH
2
Cleared 510(K)
K
86
3709
CHALLENGE ORTHODONTIC BONDING ADHESIVE
2
Cleared 510(K)
K
86
4008
ACCLAIM* BRACKET ADHESIVE
2
Cleared 510(K)
K
86
1118
ORTHOJOIN, ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
86
1258
PERMABAND (ORTHODONTIC ADHESIVE)
2
Cleared 510(K)
K
86
0959
DEPENDABOND
2
Cleared 510(K)
K
84
4844
ESPE NIMETIC-GRIP
2
Cleared 510(K)
K
85
4050
EXCEL BRACKET ADHESIVE
2
Cleared 510(K)
K
85
3523
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
84
4133
CLEANSE N BOND I
2
Cleared 510(K)
K
84
4134
CLEANSE N BOND II
2
Cleared 510(K)
K
84
3527
ORTHOMITE 111 ADHESIVE
2
Cleared 510(K)
K
84
2448
BOSWORTH SUPER BOND DENTAL ADHESIVE
2
Cleared 510(K)
K
83
2292
SOLO-TACH
2
Cleared 510(K)
K
83
2291
AUTO-TACH
2
Cleared 510(K)
K
83
2112
NO-MIX 30 ORTHODONTIC BONDING SYSTEM
2
Cleared 510(K)
K
83
1495
CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO
2
Cleared 510(K)
K
82
3928
TOOTH CONDITIONER
2
Cleared 510(K)
K
82
3409
HELIOSIT-ORTHODONTIC
2
Cleared 510(K)
K
82
3851
ORTHODAPTIC* BONDING ADHESIVE
2
Cleared 510(K)
K
82
0092
SECURE-ON-TOUCH
2
Cleared 510(K)
K
81
2547
BEAUBON
2
Cleared 510(K)
K
81
0959
SECURE
2
Cleared 510(K)
K
81
0715
SECURE
2
Cleared 510(K)
K
81
0517
INSTA-BOND
2
Cleared 510(K)
K
81
0241
CRYSTAL-BOND
2
Cleared 510(K)
K
81
0210
MAGIC-TOUCH
2
Cleared 510(K)
K
80
0392
BRACKET BONDING SYSTEM METAL & PLASTIC
2
Cleared 510(K)
K
79
2003
1 STEP
2
Cleared 510(K)
K
79
1132
SCI-PHARM ORTHODONTIC ADHESIVE
2
Cleared 510(K)
K
79
0962
SEAL & BOND DIRECT BONDING ORTHODONTIC
2
Cleared 510(K)
K
78
0334
ADHESIVE, BRACKET AND CONDITIONER RESIN
2
Cleared 510(K)
K
78
0028
ORTHODONTIC. PLASTIC BRACKET PRIMER
2
Cleared 510(K)
K
77
2126
TEMP. BRIDGE, POSTERIOR 3-UNIT
2
Cleared 510(K)
K
77
1883
REPLICA ACID-ETCH
2
Cleared 510(K)
K
77
1076
ORTHODONTIC BRACKET ADHESIVE
2
Cleared 510(K)
K
76
0378
CEMENT, RESIN DENTAL (AUTO-TACH)
2
Cleared 510(K)
K
76
0376
CEMENT, RESIN DENTAL (SOLO-TACH)
2
Cleared 510(K)
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
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
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
DE
/
subpart-d—prosthetic-devices
/
DYH
/
K930614
View Source
ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930614
510(k) Type
Traditional
Applicant
WALLACE A. ERICKSON & CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/17/1993
Days to Decision
132 days
Submission Type
Statement
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
K
25
0015
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
K
24
2537
BracePaste Fluoride Sealant
K
23
4043
3M™ Transbond™ Orthodontic Adhesive
K
23
1817
AlignerFlow LC
K
21
4054
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
K
21
0115
FiteBac CC OrthoSeal
K
20
2276
BracePaste Band and Build LC
K
19
2682
Orthocem, Ortho Bite
K
19
3388
GlassLok Kits, GlassLok Powder, GlassLok Liquid
K
18
3147
BrackFix
K
17
3020
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K
16
0782
BracePaste Adhesive
K
16
1684
Quantum LB
K
15
0128
GC Ortho Connect, GC Ortho Etching Gel
K
14
3667
GC KommonBase
K
14
2886
DMRC Self-Cure Bracket Adhesive One Step and Primer
K
14
2881
DMRC Dual Cure Orthodontic Band Cement
K
14
2880
DMRC Light Cure Orthodontic Adhesive System
K
12
3348
CLEAR ALIGNER ADHESIVE
K
12
0619
ORTHODONTIC FLOWABLE BRACKET ADHESIVE
K
11
3401
ORTHO-1(NOT FINALIZED)
K
11
3197
APC FLASH-FREE ADHESIVE
K
11
1814
PADLOCK
K
11
1696
OPAL BAND CEMENT
K
10
1951
LIGHT CURE RETAINER
K
10
0536
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
K
10
0301
OPAL BOND FLOW
K
09
4006
OPAL BOND MV
K
09
3221
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
K
09
0355
OPAL SEAL
K
08
3051
FLOWTAIN & FLOWTAIN LV
K
08
0445
LION SE ONE STEP ORTHODONTIC ADHESIVE
K
08
0724
GC OPB-100
K
08
1291
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
K
07
3697
TRANSBOND SUPREME ADHESIVE
K
07
3588
GC MODELS OPA-100 AND JC-50
K
07
2978
TENDER ORTHO BOND-ENA BOND-ENA ETCH
K
07
2830
RM BOND, MODEL J032
K
07
1590
THERMA-CURE
K
06
1252
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
K
06
1481
GRENGLOO
K
05
3379
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
K
05
0750
LC BRACKET ADHESIVE SYSTEM
K
04
2422
D3 CHROMA
K
04
0375
IDEAL 1 ORTHODONTIC BAND CEMENT
K
04
0548
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
K
04
0547
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
K
03
3703
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K
03
3551
EVOLVE
K
03
0644
CONTEC DUO, CONTEC LC, CONTEC LCR
K
03
2195
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
K
03
2407
OPTIBAND LC
K
03
2042
ENVISION
K
03
0980
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
K
03
0977
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
K
03
1420
S & C -BRACKET ADHESIVES
K
03
0036
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
K
02
2224
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
K
02
0648
GRIDLOCK 195 ADHESIVE
K
02
0502
SOLO ORTHO 3
K
02
0578
GC FUJI ORTHO BAND PASTE PAK
K
02
0394
APC PLUS ADHESIVE
K
01
4138
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K
01
4133
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K
02
0115
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K
01
4142
UNITE BONDING ADHESIVE
K
01
4059
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K
01
2673
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
K
01
2032
FIRST SPEP
K
01
0544
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
K
01
1521
ORTHO VLC; ORTHO VLC CAPSULE
K
00
1881
IMPROVED ENLIGHT LV
K
00
1446
LIGHT-CURED ORTHODONTIC BAND CEMENT
K
00
1048
LIGHT BOND (QUICK CURE)
K
99
4309
SOLO ORTHO 2
K
99
0743
SOLO ORTHO
K
98
1036
SMARTBOND
K
99
0252
SOLO PLUS ORTHO
K
98
4362
ENLIGHT LV
K
98
4217
ENLIGHT-2
K
98
1461
GC FUJI ORTHO LC
K
97
2890
ENLIGHT (TENTATIVE NAME)
K
96
2946
ORTHO-ONE
K
96
1417
GC FUJI ORTHO
K
95
5329
RESILIENCE M5 PROTECTION PLUS
K
95
4374
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
K
95
4373
AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
K
95
4372
AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
K
95
4333
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM
K
95
4244
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE
K
95
2856
LIGHT-CURE PC
K
95
2855
PC-LOCK
K
95
2858
LIGHT-CURE
K
95
2857
PRO-LOCK
K
95
3217
PULPDENT TOUCHDOWN
K
95
2854
PULPDENT GLASS IONOMER CEMENTS
K
95
2643
RIGHT-ON ADHESIVE BOUDING SYSTEM
K
95
1380
VILA PC
K
95
1381
VILA
K
95
1235
GIROC
K
95
1236
PRO-LOCK
K
95
0556
FUJI ORTHO LC
K
95
0512
AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
K
95
0514
TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
K
94
6255
THERMASET
K
94
2742
ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV
K
94
2727
ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE
K
93
5625
ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
K
94
1015
ORMCO SYSTEM 1+ (TM)
K
94
0845
SYSTEM 1
K
93
5714
CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE
K
92
5359
RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS
K
93
0614
ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST
K
92
1283
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K
92
1044
ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND
K
92
3399
CHALLENGE II - PASTE ADHESIVE
K
92
1245
THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II
K
92
1385
IMPROVED SEQUENCE LIGHT CURE ADHESIVE
K
92
0781
FLASH BOND
K
92
0534
PORCELAIN PRIMER
K
91
4317
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
K
91
4727
SEQUENCE LIGHT CURE ADHESIVE
K
91
3854
ORTHO LIGHT CURE
K
91
1286
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K
91
1271
ADHESIVE PRECOATED BRACKETS
K
90
4090
ORTHODONTIC BONDING ADHESIVE CONTROL
K
91
0803
ENAMEL ETCHING GEL
K
89
5523
PHASE II ORTHODONTIC ADHESIVE
K
89
5521
RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)
K
89
5522
LIGHT BOND PASTE W/FLUORIDE
K
89
5163
FORCE II
K
89
4639
SKYROCK AND LIGHT SUPERBOND
K
89
4565
LIGHT BOND SEALANT WITH FLUORIDE
K
89
4566
MAXIMUM CURE SEALANT WITH FLUORIDE
K
89
3396
AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
K
89
3255
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
K
89
3037
NO-MIX 30 ORTHODONTIC BONDING SYSTEMS
K
89
1464
RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4
K
89
0834
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K
89
0740
FRS LITE FLUORIDE RELEASING SEALANT
K
88
4575
MAXIBOND
K
88
3465
ORTHO-SEAL
K
88
0562
ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT
K
88
0793
LIGHT BOND
K
88
0791
MAXIMUM CURE SEALANT
K
88
0766
RELIANCE METAL PRIMER
K
88
0792
PLASTIC PRIMER
K
88
0790
PORCELAIN PRIMER
K
88
0393
TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE
K
87
4228
BOND FAST NO MIX ADHESIVE
K
87
5142
PHASE II
K
87
5144
EXCEL FAST SET
K
87
5141
EXCEL REGULAR SET
K
87
5143
RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
K
87
1591
ORMCO GEL-ETCH
K
86
3709
CHALLENGE ORTHODONTIC BONDING ADHESIVE
K
86
4008
ACCLAIM* BRACKET ADHESIVE
K
86
1118
ORTHOJOIN, ORTHODONTIC ADHESIVE
K
86
1258
PERMABAND (ORTHODONTIC ADHESIVE)
K
86
0959
DEPENDABOND
K
84
4844
ESPE NIMETIC-GRIP
K
85
4050
EXCEL BRACKET ADHESIVE
K
85
3523
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K
84
4133
CLEANSE N BOND I
K
84
4134
CLEANSE N BOND II
K
84
3527
ORTHOMITE 111 ADHESIVE
K
84
2448
BOSWORTH SUPER BOND DENTAL ADHESIVE
K
83
2292
SOLO-TACH
K
83
2291
AUTO-TACH
K
83
2112
NO-MIX 30 ORTHODONTIC BONDING SYSTEM
K
83
1495
CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO
K
82
3928
TOOTH CONDITIONER
K
82
3409
HELIOSIT-ORTHODONTIC
K
82
3851
ORTHODAPTIC* BONDING ADHESIVE
K
82
0092
SECURE-ON-TOUCH
K
81
2547
BEAUBON
K
81
0959
SECURE
K
81
0715
SECURE
K
81
0517
INSTA-BOND
K
81
0241
CRYSTAL-BOND
K
81
0210
MAGIC-TOUCH
K
80
0392
BRACKET BONDING SYSTEM METAL & PLASTIC
K
79
2003
1 STEP
K
79
1132
SCI-PHARM ORTHODONTIC ADHESIVE
K
79
0962
SEAL & BOND DIRECT BONDING ORTHODONTIC
K
78
0334
ADHESIVE, BRACKET AND CONDITIONER RESIN
K
78
0028
ORTHODONTIC. PLASTIC BRACKET PRIMER
K
77
2126
TEMP. BRIDGE, POSTERIOR 3-UNIT
K
77
1883
REPLICA ACID-ETCH
K
77
1076
ORTHODONTIC BRACKET ADHESIVE
K
76
0378
CEMENT, RESIN DENTAL (AUTO-TACH)
K
76
0376
CEMENT, RESIN DENTAL (SOLO-TACH)
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
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
/
DYH
/
K930614
View Source
ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930614
510(k) Type
Traditional
Applicant
WALLACE A. ERICKSON & CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/17/1993
Days to Decision
132 days
Submission Type
Statement