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Innolitics
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Review Panel
Cardiovascular
Review Panel
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Dental
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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
K
23
2498
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
2
Cleared 510(K)
K
23
0455
Enamel Coating Resin
2
Cleared 510(K)
K
19
0998
BA Pit & Fissure Sealant
2
Cleared 510(K)
K
19
0339
Helioseal F Plus
2
Cleared 510(K)
K
17
2169
Pulpdent (Activa) Pit and Fissure Sealant with MCP
2
Cleared 510(K)
K
17
1330
Nanova Sealant
2
Cleared 510(K)
K
16
2598
HAPI Seal
2
Cleared 510(K)
K
16
1580
Premier Sealant
2
Cleared 510(K)
K
14
1717
PACSEAL PIT & FISSURE SEALANT
2
Cleared 510(K)
K
13
0485
CONTROL SEAL
2
Cleared 510(K)
K
12
2521
PREVENT SEAL
2
Cleared 510(K)
K
11
3818
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
2
Cleared 510(K)
K
11
2517
ULTRASEAL XT HYDRO
2
Cleared 510(K)
K
11
1782
BEAUTISEALANT
2
Cleared 510(K)
K
11
0058
BPA-FREE PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
10
2252
DMP PIT & FISSURE SEALANT
2
Cleared 510(K)
K
10
3121
ECO-S
2
Cleared 510(K)
K
10
1245
ULTRASEAL ID
2
Cleared 510(K)
K
10
0062
INFILTRATION KIT
2
Cleared 510(K)
K
09
3059
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
09
1632
SPK SEALANT
2
Cleared 510(K)
K
09
1635
VENUS DIAMOND FLOW
2
Cleared 510(K)
K
08
3473
CLEAR BRAVO
2
Cleared 510(K)
K
08
1493
INFILTRATION KIT
2
Cleared 510(K)
K
07
1158
AURALAY PIT & FISSURE SEALANT
2
Cleared 510(K)
K
06
2886
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
2
Cleared 510(K)
K
06
1997
PREMIER SELF-ETCHING ENAMEL SEALANT
2
Cleared 510(K)
K
06
2344
GRANDIO SEAL
2
Cleared 510(K)
K
06
1823
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
2
Cleared 510(K)
K
05
2281
EMBRACE WETBOND CLEAR SEALANT
2
Cleared 510(K)
K
05
3089
ASCENT PIT & FISSURE SEALANT
2
Cleared 510(K)
K
05
1224
BOSWORTH SEAL
2
Cleared 510(K)
K
05
0871
RIVA PROTECT
2
Cleared 510(K)
K
05
0959
DELTON ILLUMINATING PIT AND FISSURE SEALING
2
Cleared 510(K)
K
04
2823
COSMEDENT PIT & FISSURE SEALANT
2
Cleared 510(K)
K
03
3751
AEGIS PIT & FISSURE SEALANT WITH ACP
2
Cleared 510(K)
K
03
1811
PIT & FISSURE SEALANT WITH FLUORIDE
2
Cleared 510(K)
K
02
1842
ADMIRA SEAL
2
Cleared 510(K)
K
02
1844
ADMIRA PROTECT
2
Cleared 510(K)
K
02
0287
DENTITION INTEGRATING MATERIAL
2
Cleared 510(K)
K
01
2761
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
2
Cleared 510(K)
K
01
2542
REVOTEK LC
2
Cleared 510(K)
K
01
2742
TEETHMATE F-1
2
Cleared 510(K)
K
01
1908
OPTIBOND SOLO PLUS 3
2
Cleared 510(K)
K
01
1491
HELIOSEAL CLEAR CHROMA
2
Cleared 510(K)
K
01
1822
PIT AND FISSURE CHEMICAL CURING SEALANT
2
Cleared 510(K)
K
99
3846
ULTRASEAL XT PLUS
2
Cleared 510(K)
K
99
2519
NRC NON-RINSE CONDITIONER
2
Cleared 510(K)
K
99
2326
3M CLINPRO SEALANT
2
Cleared 510(K)
K
99
2518
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
2
Cleared 510(K)
K
99
2516
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
2
Cleared 510(K)
K
99
1909
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
2
Cleared 510(K)
K
99
1902
LC PIT & FISSURE SEALANT
2
Cleared 510(K)
K
99
1099
AMERICAN DENTAL PRODUCTS ETCH-DETECT
2
Cleared 510(K)
K
99
0650
CONSEAL F
2
Cleared 510(K)
K
99
0306
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
2
Cleared 510(K)
K
98
2564
DELTON FS DIRECT DELIVERY SYSTEM
2
Cleared 510(K)
K
97
3541
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
2
Cleared 510(K)
K
96
5091
TEETHMATE F-1
2
Cleared 510(K)
K
96
3921
PULPDENT SEAL-RITE UDMA
2
Cleared 510(K)
K
96
1190
GLY-ETCH
2
Cleared 510(K)
K
95
4867
IONOSIT SEAL
2
Cleared 510(K)
K
95
4827
SEALITE FL
2
Cleared 510(K)
K
95
4701
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
2
Cleared 510(K)
K
95
2240
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
2
Cleared 510(K)
K
95
1296
DELTON F PIT & FISSURE SEALANT
2
Cleared 510(K)
K
94
5378
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
93
5727
P&FS PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
93
2794
PULPDENT SEAL-RITE LOW VISCOSITY
2
Cleared 510(K)
K
93
2078
HELIOSEAL F
2
Cleared 510(K)
K
93
2002
BARITONE C2, MODIFICATION
2
Cleared 510(K)
K
93
1869
ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE
2
Cleared 510(K)
K
93
1868
PRIMADRY PRODUCT LINE
2
Cleared 510(K)
K
93
1857
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT
2
Cleared 510(K)
K
92
4824
MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE
2
Cleared 510(K)
K
92
3895
QUIKSEAL
2
Cleared 510(K)
K
92
4635
ALPHA-DENT PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
92
1600
ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE
2
Cleared 510(K)
K
92
1599
ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN
2
Cleared 510(K)
K
91
3853
FISSURE SEALER
2
Cleared 510(K)
K
91
5095
ESTISEAL LC
2
Cleared 510(K)
K
91
4322
BARITONE C2 & BARITONE L3
2
Cleared 510(K)
K
91
4319
PIT AND FISSURE SEALANT PRODUCTS
2
Cleared 510(K)
K
91
1287
PULPDENT SEAL RITE
2
Cleared 510(K)
K
91
0813
MET-ETCH
2
Cleared 510(K)
K
90
5582
POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND
2
Cleared 510(K)
K
90
2742
DEGUFILL (TM) WHIT-SEALANT
2
Cleared 510(K)
K
90
2022
SEAL RITE(TM)
2
Cleared 510(K)
K
90
2023
SEAL RITE PROCEDURE KIT(TM)
2
Cleared 510(K)
K
89
6341
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
2
Cleared 510(K)
K
89
7027
TEETHMATE-A
2
Cleared 510(K)
K
89
1140
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
2
Cleared 510(K)
K
89
0494
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
2
Cleared 510(K)
K
89
0464
ZENITH 40% PHOSPHORIC ACID GEL
2
Cleared 510(K)
K
87
5091
ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
87
4944
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
2
Cleared 510(K)
K
87
4556
BISCO PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
87
4557
BISCO PORCELAIN REPAIR KIT
2
Cleared 510(K)
K
87
3069
MODIFIED VISIO-SEAL
2
Cleared 510(K)
K
87
0579
ALPHA-DENT PIT AND FISSURE SEALANT
2
Cleared 510(K)
K
86
2695
FLUOR-ETCH GEL ETCHANT
2
Cleared 510(K)
K
86
2660
PRISMA METAL OPAQUERS
2
Cleared 510(K)
K
86
2284
SEALITE
2
Cleared 510(K)
K
86
1245
ORTHOSOURCE ETCH SYSTEMS
2
Cleared 510(K)
K
85
4882
PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
2
Cleared 510(K)
K
85
4494
CERAM-ETCH
2
Cleared 510(K)
K
84
5034
FOREMOST LITE CURE PIT & FISSURE SEALANT
2
Cleared 510(K)
K
84
4308
PIT AND FISSURE SEAANTS
2
Cleared 510(K)
K
84
4211
CONCISE LIGHT CURED WHITE SEALANT
2
Cleared 510(K)
K
84
4057
C-22 PIT & FISSURE SEALANT
2
Cleared 510(K)
K
84
3024
COMMAND ULTRASEAL PIT & FISSURE SEALANT
2
Cleared 510(K)
K
84
3098
APCO FISSURE SEALER & BONDING AGENT
2
Cleared 510(K)
K
84
2392
DELTON * OPAQUE LIGHT CURING PIT
2
Cleared 510(K)
K
83
1380
DELTON LIGHT CURING PIT & FISSURE
2
Cleared 510(K)
K
81
3015
HELIOSEAL
2
Cleared 510(K)
K
81
3091
FISSURE SEALER & BONDING AGENT
2
Cleared 510(K)
K
81
2549
BEAUSEAL
2
Cleared 510(K)
K
81
1624
VISIO-SEAL
2
Cleared 510(K)
K
81
0950
VISIO-SEAL
2
Cleared 510(K)
K
80
2682
CONTACT SEAL
2
Cleared 510(K)
K
80
2562
PRISMA SEAL
2
Cleared 510(K)
K
80
1274
S.S. WHITE-PENNWALT PRELUDE PIT SEALANT
2
Cleared 510(K)
K
80
0391
PAINT-ON-RESTORATIVE W/FISSURE SEALER
2
Cleared 510(K)
K
79
0935
DELTON* PIT AND FISSURE SEALENT
2
Cleared 510(K)
K
79
0788
FISSURE SEALER AND BONDING AGENT
2
Cleared 510(K)
K
79
0596
ENAMEL BOND SYSTEM
2
Cleared 510(K)
K
77
1402
NUVA-COTE (MODIFICATION TO)
2
Cleared 510(K)
K
77
1327
UVIOFIL
2
Cleared 510(K)
K
76
0418
9075
2
Cleared 510(K)
K
76
0405
SEALANT, NEW FILLED
2
Cleared 510(K)
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
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Last synced on 23 May 2025 at 11:06 pm
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subpart-d—prosthetic-devices
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EBC
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K990306
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HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990306
510(k) Type
Traditional
Applicant
KAY SEE DENTAL MFG. CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/1999
Days to Decision
30 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
K
23
2498
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K
23
0455
Enamel Coating Resin
K
19
0998
BA Pit & Fissure Sealant
K
19
0339
Helioseal F Plus
K
17
2169
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K
17
1330
Nanova Sealant
K
16
2598
HAPI Seal
K
16
1580
Premier Sealant
K
14
1717
PACSEAL PIT & FISSURE SEALANT
K
13
0485
CONTROL SEAL
K
12
2521
PREVENT SEAL
K
11
3818
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K
11
2517
ULTRASEAL XT HYDRO
K
11
1782
BEAUTISEALANT
K
11
0058
BPA-FREE PIT AND FISSURE SEALANT
K
10
2252
DMP PIT & FISSURE SEALANT
K
10
3121
ECO-S
K
10
1245
ULTRASEAL ID
K
10
0062
INFILTRATION KIT
K
09
3059
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
K
09
1632
SPK SEALANT
K
09
1635
VENUS DIAMOND FLOW
K
08
3473
CLEAR BRAVO
K
08
1493
INFILTRATION KIT
K
07
1158
AURALAY PIT & FISSURE SEALANT
K
06
2886
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K
06
1997
PREMIER SELF-ETCHING ENAMEL SEALANT
K
06
2344
GRANDIO SEAL
K
06
1823
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K
05
2281
EMBRACE WETBOND CLEAR SEALANT
K
05
3089
ASCENT PIT & FISSURE SEALANT
K
05
1224
BOSWORTH SEAL
K
05
0871
RIVA PROTECT
K
05
0959
DELTON ILLUMINATING PIT AND FISSURE SEALING
K
04
2823
COSMEDENT PIT & FISSURE SEALANT
K
03
3751
AEGIS PIT & FISSURE SEALANT WITH ACP
K
03
1811
PIT & FISSURE SEALANT WITH FLUORIDE
K
02
1842
ADMIRA SEAL
K
02
1844
ADMIRA PROTECT
K
02
0287
DENTITION INTEGRATING MATERIAL
K
01
2761
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
K
01
2542
REVOTEK LC
K
01
2742
TEETHMATE F-1
K
01
1908
OPTIBOND SOLO PLUS 3
K
01
1491
HELIOSEAL CLEAR CHROMA
K
01
1822
PIT AND FISSURE CHEMICAL CURING SEALANT
K
99
3846
ULTRASEAL XT PLUS
K
99
2519
NRC NON-RINSE CONDITIONER
K
99
2326
3M CLINPRO SEALANT
K
99
2518
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K
99
2516
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
K
99
1909
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K
99
1902
LC PIT & FISSURE SEALANT
K
99
1099
AMERICAN DENTAL PRODUCTS ETCH-DETECT
K
99
0650
CONSEAL F
K
99
0306
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
K
98
2564
DELTON FS DIRECT DELIVERY SYSTEM
K
97
3541
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
K
96
5091
TEETHMATE F-1
K
96
3921
PULPDENT SEAL-RITE UDMA
K
96
1190
GLY-ETCH
K
95
4867
IONOSIT SEAL
K
95
4827
SEALITE FL
K
95
4701
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
K
95
2240
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
K
95
1296
DELTON F PIT & FISSURE SEALANT
K
94
5378
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
K
93
5727
P&FS PIT AND FISSURE SEALANT
K
93
2794
PULPDENT SEAL-RITE LOW VISCOSITY
K
93
2078
HELIOSEAL F
K
93
2002
BARITONE C2, MODIFICATION
K
93
1869
ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE
K
93
1868
PRIMADRY PRODUCT LINE
K
93
1857
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT
K
92
4824
MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE
K
92
3895
QUIKSEAL
K
92
4635
ALPHA-DENT PIT AND FISSURE SEALANT
K
92
1600
ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE
K
92
1599
ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN
K
91
3853
FISSURE SEALER
K
91
5095
ESTISEAL LC
K
91
4322
BARITONE C2 & BARITONE L3
K
91
4319
PIT AND FISSURE SEALANT PRODUCTS
K
91
1287
PULPDENT SEAL RITE
K
91
0813
MET-ETCH
K
90
5582
POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND
K
90
2742
DEGUFILL (TM) WHIT-SEALANT
K
90
2022
SEAL RITE(TM)
K
90
2023
SEAL RITE PROCEDURE KIT(TM)
K
89
6341
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K
89
7027
TEETHMATE-A
K
89
1140
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
K
89
0494
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
K
89
0464
ZENITH 40% PHOSPHORIC ACID GEL
K
87
5091
ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT
K
87
4944
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K
87
4556
BISCO PIT AND FISSURE SEALANT
K
87
4557
BISCO PORCELAIN REPAIR KIT
K
87
3069
MODIFIED VISIO-SEAL
K
87
0579
ALPHA-DENT PIT AND FISSURE SEALANT
K
86
2695
FLUOR-ETCH GEL ETCHANT
K
86
2660
PRISMA METAL OPAQUERS
K
86
2284
SEALITE
K
86
1245
ORTHOSOURCE ETCH SYSTEMS
K
85
4882
PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
K
85
4494
CERAM-ETCH
K
84
5034
FOREMOST LITE CURE PIT & FISSURE SEALANT
K
84
4308
PIT AND FISSURE SEAANTS
K
84
4211
CONCISE LIGHT CURED WHITE SEALANT
K
84
4057
C-22 PIT & FISSURE SEALANT
K
84
3024
COMMAND ULTRASEAL PIT & FISSURE SEALANT
K
84
3098
APCO FISSURE SEALER & BONDING AGENT
K
84
2392
DELTON * OPAQUE LIGHT CURING PIT
K
83
1380
DELTON LIGHT CURING PIT & FISSURE
K
81
3015
HELIOSEAL
K
81
3091
FISSURE SEALER & BONDING AGENT
K
81
2549
BEAUSEAL
K
81
1624
VISIO-SEAL
K
81
0950
VISIO-SEAL
K
80
2682
CONTACT SEAL
K
80
2562
PRISMA SEAL
K
80
1274
S.S. WHITE-PENNWALT PRELUDE PIT SEALANT
K
80
0391
PAINT-ON-RESTORATIVE W/FISSURE SEALER
K
79
0935
DELTON* PIT AND FISSURE SEALENT
K
79
0788
FISSURE SEALER AND BONDING AGENT
K
79
0596
ENAMEL BOND SYSTEM
K
77
1402
NUVA-COTE (MODIFICATION TO)
K
77
1327
UVIOFIL
K
76
0418
9075
K
76
0405
SEALANT, NEW FILLED
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
/
EBC
/
K990306
View Source
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990306
510(k) Type
Traditional
Applicant
KAY SEE DENTAL MFG. CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/3/1999
Days to Decision
30 days
Submission Type
Summary