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Innolitics
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Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
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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
K
24
3353
One-Fil Putty
2
Cleared 510(K)
K
24
3546
AH Plus Endodontic Sealer
2
Cleared 510(K)
K
24
2934
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
2
Cleared 510(K)
K
24
2702
VioSeal
2
Cleared 510(K)
K
24
1977
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
2
Cleared 510(K)
K
24
1457
Vista BC Putty
2
Cleared 510(K)
K
24
0446
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
2
Cleared 510(K)
K
24
0304
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
2
Cleared 510(K)
K
24
0365
Bioceramic Root Repair Material (C-Root BP)
2
Cleared 510(K)
K
23
2182
One-Fil
2
Cleared 510(K)
K
23
2299
CeraPutty
2
Cleared 510(K)
K
23
1480
Bright MTA Sealer Plus
2
Cleared 510(K)
K
23
1387
Endofill
2
Cleared 510(K)
K
23
1259
iRoot SP Plus
2
Cleared 510(K)
K
23
0010
ADSEAL Plus
2
Cleared 510(K)
K
23
0797
SmartMTA Capsule
2
Cleared 510(K)
K
21
3757
Endocem MTA Premixed Regular
2
Cleared 510(K)
K
22
2992
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
2
Cleared 510(K)
K
22
1811
Vista BC Sealer
2
Cleared 510(K)
K
21
2563
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
2
Cleared 510(K)
K
21
2983
Injectable Root Canal Bioceramic Sealer
2
Cleared 510(K)
K
21
1905
UltraCal XS
2
Cleared 510(K)
K
21
2283
BioRoot Flow 0.5g, BioRoot Flow 2g
2
Cleared 510(K)
K
21
1995
Sonendo Filling Material 5C
2
Cleared 510(K)
K
21
2229
White Endoseal MTA
2
Cleared 510(K)
K
21
1799
Biodentine XP 500, Biodentine XP 200
2
Cleared 510(K)
K
21
0904
Metapaste Plus
2
Cleared 510(K)
K
20
2617
Metapex Plus
2
Cleared 510(K)
K
21
0333
DiaPaste
2
Cleared 510(K)
K
20
2015
White ENDOSEAL MTA
2
Cleared 510(K)
K
20
2281
EDS Bioceramic Sealer (Bioseal)
2
Cleared 510(K)
K
20
1222
Bio-C Repair Ion+
2
Cleared 510(K)
K
20
0174
DIA-ROOT BIO MTA
2
Cleared 510(K)
K
20
0175
DIA-ROOT BIO Sealer
2
Cleared 510(K)
K
19
0091
Diapaste
2
Cleared 510(K)
K
19
0537
BIO-C Sealer Ion+
2
Cleared 510(K)
K
18
2009
Dia-Proseal
2
Cleared 510(K)
K
19
0503
CeraSeal
2
Cleared 510(K)
K
18
2625
Diapex Plus
2
Cleared 510(K)
K
19
0510
GuttaSil
2
Cleared 510(K)
K
18
1917
MTA2.3 MATERIALS
2
Cleared 510(K)
K
18
0199
BIO-C TEMP
2
Cleared 510(K)
K
18
1922
Sonendo Material A
2
Cleared 510(K)
K
18
0185
BIO-C REPAIR
2
Cleared 510(K)
K
17
0175
ENDOSEAL MTA
2
Cleared 510(K)
K
17
2839
ENDOSOLV
2
Cleared 510(K)
K
17
2701
BIO-C SEALER
2
Cleared 510(K)
K
17
0950
Well-Root ST
2
Cleared 510(K)
K
17
0207
Obturys
2
Cleared 510(K)
K
16
2661
SavDenTM MTA Root Canal Filling Materials
2
Cleared 510(K)
K
16
1239
MTA2.2 MATERIAL
2
Cleared 510(K)
K
15
1047
MTA Repair HP
2
Cleared 510(K)
K
15
3067
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
2
Cleared 510(K)
K
15
2956
Pulp Canal Sealer, Pulp Canal Sealer EWT
2
Cleared 510(K)
K
15
2959
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
2
Cleared 510(K)
K
14
2178
PROROOT MTA WHITE, PROROOT MTA GRAY
2
Cleared 510(K)
K
13
0312
IROOT FM
2
Cleared 510(K)
K
14
0132
BIODENTINE
2
Cleared 510(K)
K
14
0955
MTA2.1 MATERIAL
2
Cleared 510(K)
K
13
3042
ENDOCEM ZR
2
Cleared 510(K)
K
13
3054
ENDOSEAL
2
Cleared 510(K)
K
14
0247
MTA FILLAPEX
2
Cleared 510(K)
K
13
2825
RETROMTA-ORTHOMTA II
2
Cleared 510(K)
K
13
3716
TRC-PASTE
2
Cleared 510(K)
K
13
2123
TRC-PEX, RADIC-SEALER
2
Cleared 510(K)
K
12
3276
MM-SEAL
2
Cleared 510(K)
K
13
0601
BIOROOT RCS
2
Cleared 510(K)
K
13
0125
MTA CEMENTS
2
Cleared 510(K)
K
12
2892
MTA2 ROOT AND PULP MATERIALS
2
Cleared 510(K)
K
11
3568
MTA-FILLAPEX
2
Cleared 510(K)
K
12
0048
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
2
Cleared 510(K)
K
11
2078
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
2
Cleared 510(K)
K
11
2046
MTA ANGELUS
2
Cleared 510(K)
K
10
2867
IROOT FS
2
Cleared 510(K)
K
10
2575
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
2
Cleared 510(K)
K
10
0248
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
2
Cleared 510(K)
K
10
2163
REALSEAL XT SEALER
2
Cleared 510(K)
K
09
3208
SIMPLISEAL
2
Cleared 510(K)
K
09
2251
BIODENTINE
2
Cleared 510(K)
K
09
2715
IROOT BP PLUS
2
Cleared 510(K)
K
09
0992
WELL-PASTE
2
Cleared 510(K)
K
08
3062
ROOT CANAL XR
2
Cleared 510(K)
K
08
2943
IROOT BP, MODEL IRBP 4609
2
Cleared 510(K)
K
08
0917
IROOT SP
2
Cleared 510(K)
K
08
0203
MTA ROOT CANAL SEALER
2
Cleared 510(K)
K
08
0266
WELL-PEX
2
Cleared 510(K)
K
07
3218
MTA ADVANCED MATERIAL
2
Cleared 510(K)
K
07
1106
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
2
Cleared 510(K)
K
06
3856
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
2
Cleared 510(K)
K
06
3422
BIOAGGREGATE
2
Cleared 510(K)
K
06
0889
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
2
Cleared 510(K)
K
06
0946
CZ-S2000
2
Cleared 510(K)
K
04
2769
ADSEAL ROOT CANAL SEALER
2
Cleared 510(K)
K
04
2756
ENDOREZ
2
Cleared 510(K)
K
03
3585
DIAPEX
2
Cleared 510(K)
K
03
2662
GUTTAFLOW
2
Cleared 510(K)
K
03
2605
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
2
Cleared 510(K)
K
03
2603
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
2
Cleared 510(K)
K
02
3818
FIBERFILL AGP
2
Cleared 510(K)
K
02
3976
ACROSEAL ROOT CANAL OR APICAL SEALER
2
Cleared 510(K)
K
02
2734
PULPDENT CALCIUM HYDROXIDE PREPARATION
2
Cleared 510(K)
K
01
1748
FIRST FILL R.C.S.
2
Cleared 510(K)
K
01
0940
SEALAPEX 4
2
Cleared 510(K)
K
01
1009
WHITE MTA MATERIAL
2
Cleared 510(K)
K
99
2727
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
2
Cleared 510(K)
K
99
2097
ENDOREZ
2
Cleared 510(K)
K
98
3037
ROEKO SEAL
2
Cleared 510(K)
K
98
1620
MTA MATERIAL II
2
Cleared 510(K)
K
98
0633
ENDOSOLV E
2
Cleared 510(K)
K
98
0332
MTA MATERIAL
2
Cleared 510(K)
K
97
3667
VITAPEX PRE-LOADED DENTAL SYRINGE
2
Cleared 510(K)
K
97
2369
SEALAPEX
2
Cleared 510(K)
K
97
1899
ENDO-SEAL
2
Cleared 510(K)
K
97
1622
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
2
Cleared 510(K)
K
96
4174
MINERAL TRIOXIDE AGGREGATE (MTA)
2
Cleared 510(K)
K
96
3922
ALPHA-DENT ROOT CANAL SEALER & FILLER
2
Cleared 510(K)
K
96
2885
SEALEX EXTRA ROOT CANAL SEALER
2
Cleared 510(K)
K
95
5703
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
2
Cleared 510(K)
K
96
0548
AH PLUS ROOT CANAL SEALER
2
Cleared 510(K)
K
94
6138
PULPDENT ROOT CANAL SEALER
2
Cleared 510(K)
K
94
0368
CANAL KING (THIN) CANAL KING (THICK)
2
Cleared 510(K)
K
94
2393
TUBLI-SEAL EWT
2
Cleared 510(K)
K
93
0872
ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA
2
Cleared 510(K)
K
93
2791
PULPDENT EDTA PREPARATIONS
2
Cleared 510(K)
K
91
4325
ROOT CANAL FILLING CEMENT
2
Cleared 510(K)
K
89
6656
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
2
Cleared 510(K)
K
89
6657
ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
2
Cleared 510(K)
K
89
4092
DENTAL ENDODONTIC CEMENT (MODIFICATION)
2
Cleared 510(K)
K
89
3794
APEXIT ROOT CANAL SEALER
2
Cleared 510(K)
K
85
4253
ROOT CANAL FILLING RESIN
2
Cleared 510(K)
K
84
4635
HYDROSET ROOT CANAL SEALER
2
Cleared 510(K)
K
83
0763
FR ROOT CANAL FILLER
2
Cleared 510(K)
K
82
0284
ROOT CANAL FILLING RESIN
2
Cleared 510(K)
K
81
0923
LEE ENDOFILL, ROOT CANAL FILLING RESIN
2
Cleared 510(K)
K
80
1482
HYDRON ROOT CANAL FILLING MATERIAL
2
Cleared 510(K)
K
77
1921
HYDRON ROOT CANAL FILLING SYSTEM
2
Cleared 510(K)
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 2 May 2025 at 11:05 pm
DE
/
subpart-d—prosthetic-devices
/
KIF
/
K231480
View Source
Bright MTA Sealer Plus
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231480
510(k) Type
Traditional
Applicant
Genoss Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/28/2023
Days to Decision
67 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
K
24
3353
One-Fil Putty
K
24
3546
AH Plus Endodontic Sealer
K
24
2934
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
K
24
2702
VioSeal
K
24
1977
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
K
24
1457
Vista BC Putty
K
24
0446
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
K
24
0304
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
K
24
0365
Bioceramic Root Repair Material (C-Root BP)
K
23
2182
One-Fil
K
23
2299
CeraPutty
K
23
1480
Bright MTA Sealer Plus
K
23
1387
Endofill
K
23
1259
iRoot SP Plus
K
23
0010
ADSEAL Plus
K
23
0797
SmartMTA Capsule
K
21
3757
Endocem MTA Premixed Regular
K
22
2992
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
K
22
1811
Vista BC Sealer
K
21
2563
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
K
21
2983
Injectable Root Canal Bioceramic Sealer
K
21
1905
UltraCal XS
K
21
2283
BioRoot Flow 0.5g, BioRoot Flow 2g
K
21
1995
Sonendo Filling Material 5C
K
21
2229
White Endoseal MTA
K
21
1799
Biodentine XP 500, Biodentine XP 200
K
21
0904
Metapaste Plus
K
20
2617
Metapex Plus
K
21
0333
DiaPaste
K
20
2015
White ENDOSEAL MTA
K
20
2281
EDS Bioceramic Sealer (Bioseal)
K
20
1222
Bio-C Repair Ion+
K
20
0174
DIA-ROOT BIO MTA
K
20
0175
DIA-ROOT BIO Sealer
K
19
0091
Diapaste
K
19
0537
BIO-C Sealer Ion+
K
18
2009
Dia-Proseal
K
19
0503
CeraSeal
K
18
2625
Diapex Plus
K
19
0510
GuttaSil
K
18
1917
MTA2.3 MATERIALS
K
18
0199
BIO-C TEMP
K
18
1922
Sonendo Material A
K
18
0185
BIO-C REPAIR
K
17
0175
ENDOSEAL MTA
K
17
2839
ENDOSOLV
K
17
2701
BIO-C SEALER
K
17
0950
Well-Root ST
K
17
0207
Obturys
K
16
2661
SavDenTM MTA Root Canal Filling Materials
K
16
1239
MTA2.2 MATERIAL
K
15
1047
MTA Repair HP
K
15
3067
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
K
15
2956
Pulp Canal Sealer, Pulp Canal Sealer EWT
K
15
2959
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
K
14
2178
PROROOT MTA WHITE, PROROOT MTA GRAY
K
13
0312
IROOT FM
K
14
0132
BIODENTINE
K
14
0955
MTA2.1 MATERIAL
K
13
3042
ENDOCEM ZR
K
13
3054
ENDOSEAL
K
14
0247
MTA FILLAPEX
K
13
2825
RETROMTA-ORTHOMTA II
K
13
3716
TRC-PASTE
K
13
2123
TRC-PEX, RADIC-SEALER
K
12
3276
MM-SEAL
K
13
0601
BIOROOT RCS
K
13
0125
MTA CEMENTS
K
12
2892
MTA2 ROOT AND PULP MATERIALS
K
11
3568
MTA-FILLAPEX
K
12
0048
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
K
11
2078
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
K
11
2046
MTA ANGELUS
K
10
2867
IROOT FS
K
10
2575
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
K
10
0248
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
K
10
2163
REALSEAL XT SEALER
K
09
3208
SIMPLISEAL
K
09
2251
BIODENTINE
K
09
2715
IROOT BP PLUS
K
09
0992
WELL-PASTE
K
08
3062
ROOT CANAL XR
K
08
2943
IROOT BP, MODEL IRBP 4609
K
08
0917
IROOT SP
K
08
0203
MTA ROOT CANAL SEALER
K
08
0266
WELL-PEX
K
07
3218
MTA ADVANCED MATERIAL
K
07
1106
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K
06
3856
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
K
06
3422
BIOAGGREGATE
K
06
0889
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
K
06
0946
CZ-S2000
K
04
2769
ADSEAL ROOT CANAL SEALER
K
04
2756
ENDOREZ
K
03
3585
DIAPEX
K
03
2662
GUTTAFLOW
K
03
2605
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
K
03
2603
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K
02
3818
FIBERFILL AGP
K
02
3976
ACROSEAL ROOT CANAL OR APICAL SEALER
K
02
2734
PULPDENT CALCIUM HYDROXIDE PREPARATION
K
01
1748
FIRST FILL R.C.S.
K
01
0940
SEALAPEX 4
K
01
1009
WHITE MTA MATERIAL
K
99
2727
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
K
99
2097
ENDOREZ
K
98
3037
ROEKO SEAL
K
98
1620
MTA MATERIAL II
K
98
0633
ENDOSOLV E
K
98
0332
MTA MATERIAL
K
97
3667
VITAPEX PRE-LOADED DENTAL SYRINGE
K
97
2369
SEALAPEX
K
97
1899
ENDO-SEAL
K
97
1622
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
K
96
4174
MINERAL TRIOXIDE AGGREGATE (MTA)
K
96
3922
ALPHA-DENT ROOT CANAL SEALER & FILLER
K
96
2885
SEALEX EXTRA ROOT CANAL SEALER
K
95
5703
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
K
96
0548
AH PLUS ROOT CANAL SEALER
K
94
6138
PULPDENT ROOT CANAL SEALER
K
94
0368
CANAL KING (THIN) CANAL KING (THICK)
K
94
2393
TUBLI-SEAL EWT
K
93
0872
ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA
K
93
2791
PULPDENT EDTA PREPARATIONS
K
91
4325
ROOT CANAL FILLING CEMENT
K
89
6656
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K
89
6657
ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
K
89
4092
DENTAL ENDODONTIC CEMENT (MODIFICATION)
K
89
3794
APEXIT ROOT CANAL SEALER
K
85
4253
ROOT CANAL FILLING RESIN
K
84
4635
HYDROSET ROOT CANAL SEALER
K
83
0763
FR ROOT CANAL FILLER
K
82
0284
ROOT CANAL FILLING RESIN
K
81
0923
LEE ENDOFILL, ROOT CANAL FILLING RESIN
K
80
1482
HYDRON ROOT CANAL FILLING MATERIAL
K
77
1921
HYDRON ROOT CANAL FILLING SYSTEM
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
/
KIF
/
K231480
View Source
Bright MTA Sealer Plus
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231480
510(k) Type
Traditional
Applicant
Genoss Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/28/2023
Days to Decision
67 days
Submission Type
Summary