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Review Panel
Cardiovascular
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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
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
K
24
1575
Straumann® Anatomic Healing Abutments XC (AHA)
2
Cleared 510(K)
K
24
2340
DESS Dental Smart Solutions
2
Cleared 510(K)
K
24
1170
Dynamic TiBase; TRI Screws
2
Cleared 510(K)
K
24
0725
PreXolid CAD/CAM abutments
2
Cleared 510(K)
K
24
1485
TruAbutment DS; TruBase
2
Cleared 510(K)
K
23
4142
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
2
Cleared 510(K)
K
24
1722
Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment
2
Cleared 510(K)
K
24
0982
DESS Dental Smart Solutions
2
Cleared 510(K)
K
23
1932
TDS (TECHWIN DENTAL SYSTEM)
2
Cleared 510(K)
K
24
0531
SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment
2
Cleared 510(K)
Show All 647 Submissions
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 30 November 2024 at 11:09 am
DE
/
subpart-d—prosthetic-devices
/
NHA
/
K234142
View Source
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234142
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
9/18/2024
Days to Decision
264 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
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
K
24
1575
Straumann® Anatomic Healing Abutments XC (AHA)
K
24
2340
DESS Dental Smart Solutions
K
24
1170
Dynamic TiBase; TRI Screws
K
24
0725
PreXolid CAD/CAM abutments
K
24
1485
TruAbutment DS; TruBase
K
23
4142
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
K
24
1722
Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment
K
24
0982
DESS Dental Smart Solutions
K
23
1932
TDS (TECHWIN DENTAL SYSTEM)
K
24
0531
SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment
Show All 647 Submissions
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
/
NHA
/
K234142
View Source
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K234142
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
9/18/2024
Days to Decision
264 days
Submission Type
Summary