FDA Browser
by
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
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
K
23
1502
Mini Screws
2
Cleared 510(K)
K
23
1913
T-FIT
2
Cleared 510(K)
K
22
2245
ACR Screw System
2
Cleared 510(K)
K
20
2163
Mico One Orthodontic Screw
2
Cleared 510(K)
K
20
2691
Ortholock Anchorage Devices
2
Cleared 510(K)
K
21
0559
ATOZ Mini-Screw
2
Cleared 510(K)
K
21
1992
Ortho MI System
2
Cleared 510(K)
K
20
2790
Syntec Orthodontic Mini Screw Extended System
2
Cleared 510(K)
K
20
2278
OBS Anchorage Screw, Biokey Anchorage Screw
2
Cleared 510(K)
K
20
1919
Blue Sky Bio TAD
2
Cleared 510(K)
K
19
1041
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
2
Cleared 510(K)
K
19
0871
Bio-TackS Orthodontic Mini Implant
2
Cleared 510(K)
K
18
2929
BIO-RAY A-1 Anchor Screw System
2
Cleared 510(K)
K
18
1142
Absoanchor Microimplant
2
Cleared 510(K)
K
17
3623
Anchor plate
2
Cleared 510(K)
K
16
1335
Dual Top Screw System
2
Cleared 510(K)
K
16
1197
Orthodontic Screw
2
Cleared 510(K)
K
15
2297
OBS Anchorage Screw
2
Cleared 510(K)
K
14
2001
SYNTEC WETALI ORTHODONTIC MINI SCREWS
2
Cleared 510(K)
K
13
0476
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
2
Cleared 510(K)
K
12
2069
STORM MINI SCREW
2
Cleared 510(K)
K
12
0861
FIN-S MICROIMPLANT
2
Cleared 510(K)
K
11
3650
ORTHOFIX SCREW
2
Cleared 510(K)
K
11
0392
PSM LOMAS / BENEFIT SCREWS
2
Cleared 510(K)
K
11
1809
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
2
Cleared 510(K)
K
11
0275
ORTHO EASY PIN
2
Cleared 510(K)
K
10
3105
ORTHODONTIC SCREW
2
Cleared 510(K)
K
10
2769
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
2
Cleared 510(K)
K
09
3299
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
2
Cleared 510(K)
K
10
0633
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
2
Cleared 510(K)
K
09
1390
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
2
Cleared 510(K)
K
09
0476
SYNTEC ORTHODONTIC MINI SCREW
2
Cleared 510(K)
K
08
1393
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
2
Cleared 510(K)
K
07
1490
LEONE ORTHODONTIC MINI IMPLANT
2
Cleared 510(K)
K
07
3461
ORTHO ANCHOR SCREWS
2
Cleared 510(K)
K
07
2086
INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
2
Cleared 510(K)
K
06
3495
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
2
Cleared 510(K)
K
06
3770
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
2
Cleared 510(K)
K
06
3473
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
2
Cleared 510(K)
K
06
3149
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
2
Cleared 510(K)
K
06
3386
LORENZ ORTHODONTIC ANCHORAGE SYSTEM
2
Cleared 510(K)
K
06
2733
TOMAS PIN SD 6, 8, AND 10 MM
2
Cleared 510(K)
K
06
2732
TOMAS PIN 6 MM
2
Cleared 510(K)
K
06
1397
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
2
Cleared 510(K)
K
06
1230
VECTORS TEMPORARY ANCHORAGE SYSTEM
2
Cleared 510(K)
K
06
1266
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
2
Cleared 510(K)
K
06
0062
STRAUMANN ORTHOSYSTEM
2
Cleared 510(K)
K
04
2965
TOMAS PIN
2
Cleared 510(K)
K
04
0469
THE STRAUMANN ORTHO IMPLANT SYSTEM
2
Cleared 510(K)
K
98
2509
ORTHO IMPLANT AND ACCESSORIES
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
DE
/
subpart-d—prosthetic-devices
/
OAT
/
K190871
View Source
Bio-TackS Orthodontic Mini Implant
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190871
510(k) Type
Traditional
Applicant
Bio Cetec Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/17/2020
Days to Decision
289 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
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
K
23
1502
Mini Screws
K
23
1913
T-FIT
K
22
2245
ACR Screw System
K
20
2163
Mico One Orthodontic Screw
K
20
2691
Ortholock Anchorage Devices
K
21
0559
ATOZ Mini-Screw
K
21
1992
Ortho MI System
K
20
2790
Syntec Orthodontic Mini Screw Extended System
K
20
2278
OBS Anchorage Screw, Biokey Anchorage Screw
K
20
1919
Blue Sky Bio TAD
K
19
1041
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K
19
0871
Bio-TackS Orthodontic Mini Implant
K
18
2929
BIO-RAY A-1 Anchor Screw System
K
18
1142
Absoanchor Microimplant
K
17
3623
Anchor plate
K
16
1335
Dual Top Screw System
K
16
1197
Orthodontic Screw
K
15
2297
OBS Anchorage Screw
K
14
2001
SYNTEC WETALI ORTHODONTIC MINI SCREWS
K
13
0476
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
K
12
2069
STORM MINI SCREW
K
12
0861
FIN-S MICROIMPLANT
K
11
3650
ORTHOFIX SCREW
K
11
0392
PSM LOMAS / BENEFIT SCREWS
K
11
1809
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
K
11
0275
ORTHO EASY PIN
K
10
3105
ORTHODONTIC SCREW
K
10
2769
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
K
09
3299
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K
10
0633
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
K
09
1390
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
K
09
0476
SYNTEC ORTHODONTIC MINI SCREW
K
08
1393
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
K
07
1490
LEONE ORTHODONTIC MINI IMPLANT
K
07
3461
ORTHO ANCHOR SCREWS
K
07
2086
INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
K
06
3495
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
K
06
3770
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
K
06
3473
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K
06
3149
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
K
06
3386
LORENZ ORTHODONTIC ANCHORAGE SYSTEM
K
06
2733
TOMAS PIN SD 6, 8, AND 10 MM
K
06
2732
TOMAS PIN 6 MM
K
06
1397
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
K
06
1230
VECTORS TEMPORARY ANCHORAGE SYSTEM
K
06
1266
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
K
06
0062
STRAUMANN ORTHOSYSTEM
K
04
2965
TOMAS PIN
K
04
0469
THE STRAUMANN ORTHO IMPLANT SYSTEM
K
98
2509
ORTHO IMPLANT AND ACCESSORIES
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
/
OAT
/
K190871
View Source
Bio-TackS Orthodontic Mini Implant
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190871
510(k) Type
Traditional
Applicant
Bio Cetec Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/17/2020
Days to Decision
289 days
Submission Type
Summary