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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
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
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
2
Product Code
EZX
Mesh, Surgical, Metal
2
Product Code
MIB
Elastomer, Silicone Block
2
Product Code
MIC
Implant, Muscle, Pectoralis
2
Product Code
BTX
Board, Arm (With Cover), Sterile
1
Product Code
FTL
Mesh, Surgical, Polymeric
2
Product Code
FTM
Mesh, Surgical
2
Product Code
FTN
Plastic Surgery And Accessories Kit
1
Product Code
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
3
Product Code
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
3
Product Code
FWP
Prosthesis, Chin, Internal
2
Product Code
FYI
Appliance, Facial Fracture, External
1
Product Code
FZD
Prosthesis, Ear, Internal
2
Product Code
FZE
Prosthesis, Nose, Internal
2
Product Code
K
16
1548
Osseointegrated Fixtures
2
Cleared 510(K)
K
09
0803
HANSON MEDICAL FACIAL IMPLANTS
2
Cleared 510(K)
K
09
0630
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
2
Cleared 510(K)
K
07
1018
MONARCH NASAL IMPLANT
2
Cleared 510(K)
K
04
1690
MONARCH NASAL IMPLANT
2
Cleared 510(K)
K
02
1418
AART NASAL IMPLANT
2
Cleared 510(K)
K
99
2242
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
2
Cleared 510(K)
K
98
3755
NASAL DORSAL SERIES
2
Cleared 510(K)
K
98
2753
SEARE BIOMEDICAL NASAL IMPLANTS
2
Cleared 510(K)
K
98
1833
SILIMED NASAL L SHAPED IMPLANT
2
Cleared 510(K)
K
97
3573
DURALASTIC ANATOMICAL NASAL IMPLANTS
2
Cleared 510(K)
K
97
1481
DURALASTIC ANATOMICAL NASAL IMPLANTS
2
Cleared 510(K)
K
96
2824
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
2
Cleared 510(K)
K
96
1124
THE NAUTILUS
2
Cleared 510(K)
K
95
2705
SPIRIT RIDGE NASAL IMPLANT
2
Cleared 510(K)
K
95
2709
PROTHESIS, CHIN, INTERNAL
2
Cleared 510(K)
K
95
2706
SPIRIT RIDGE SILICONE CARVING BLOCK
2
Cleared 510(K)
K
95
2707
SILICONE ELASTOMER MALAR IMPLANT
2
Cleared 510(K)
K
95
2708
PECTORALIS IMPLANT
2
Cleared 510(K)
K
94
5154
BA-CPAS
2
Cleared 510(K)
K
94
1960
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
2
Cleared 510(K)
K
94
2876
IMPLANTECH DORSAL NASAL IMPLANT
2
Cleared 510(K)
K
92
5743
NASAL DORSUM
2
Cleared 510(K)
K
92
5426
RIZZO NASAL IMPLANT
2
Cleared 510(K)
K
92
1580
BRINK PRE-MAXILLARY IMPLANT
2
Cleared 510(K)
K
90
4656
FLOWERS NASAL IMPLANT
2
Cleared 510(K)
K
90
4657
FLOWERS DORSAL COLUMELLA IMPLANT
2
Cleared 510(K)
K
90
4350
CUI DORSAL COLUMELLA PROSTHESIS
2
Cleared 510(K)
K
90
3328
CUI PREMAXILLARY IMPLANT
2
Cleared 510(K)
K
90
2283
THE NAUTILUS NASAL IMPLANT
2
Cleared 510(K)
K
88
0405
SILASTIC NASAL IMPLANT S-TYPE
2
Cleared 510(K)
K
87
1071
OMEGA DORSAL COLUMELLA IMPLANTS
2
Cleared 510(K)
K
86
3942
POREX(TM) NOSE PROSTHESIS
2
Cleared 510(K)
K
86
3430
BYRON BIVALVE NASAL SPLINTS
2
Cleared 510(K)
K
86
3398
BYRON NASAL SEPTAL BUTTON
2
Cleared 510(K)
K
86
3399
BYRON DORSAL COLUMELLA IMPLANT
2
Cleared 510(K)
K
85
3945
CUI RHINOPLASTY IMPLANTS
2
Cleared 510(K)
K
82
2130
FRANCIS NASAL TUBE
2
Cleared 510(K)
K
80
1074
STRAITH NASAL IMPLANT
2
Cleared 510(K)
K
78
2104
PASTE, PRO CARE PROPHYLAXIS
2
Cleared 510(K)
K
78
1574
PLASTI-PORE SEPTAL BUTTON
2
Cleared 510(K)
FZF
Splint, Extremity, Inflatable, External
1
Product Code
GBI
Material, External Aesthetic Restoration, Used With Adhesive
1
Product Code
GBJ
Prosthesis, Adhesive, External
1
Product Code
JCQ
Prosthesis, Esophagus
2
Product Code
KCZ
Prosthesis, Breast, External, Used With Adhesive
1
Product Code
KDA
Prosthesis, Ptfe/Carbon-Fiber
2
Product Code
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
2
Product Code
LZK
Implant, Malar
2
Product Code
MCA
Tape, Surgical, Internal
2
Product Code
MNF
Implant, Temporal
2
Product Code
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
1
Product Code
NOD
Board, Arm (With Cover), Non-Sterile
1
Product Code
NOJ
Prosthesis, Breast, External, No Adhesive
1
Product Code
NOK
Material, External Aesthetic Restoration, No Adhesive
1
Product Code
NWA
Prosthesis, Tracheal, Preformed/Molded
2
Product Code
NYT
Prosthesis, Tracheal, Expandable, Polymeric
2
Product Code
ODU
Facial Implant
2
Product Code
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OOD
Surgical Film
2
Product Code
OQL
Mesh, Surgical, Deployment Balloon
2
Product Code
ORQ
Mesh, Surgical, Deployer
2
Product Code
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
2
Product Code
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
2
Product Code
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
2
Product Code
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
2
Product Code
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
2
Product Code
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
2
Product Code
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
2
Product Code
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
2
Product Code
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
2
Product Code
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
2
Product Code
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
2
Product Code
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
2
Product Code
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
2
Product Code
OXL
Mesh, Surgical, Absorbable, Organ Support
2
Product Code
OXM
Mesh, Surgical, Absorbable, Fistula
2
Product Code
OXN
Mesh, Surgical, Collagen, Fistula
2
Product Code
PIJ
Collagen Surgical Mesh Containing Drugs
2
Product Code
PQN
Carbon Dioxide Gas Controlled Tissue Expander
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
SU
/
subpart-d—prosthetic-devices
/
FZE
/
K782104
View Source
PASTE, PRO CARE PROPHYLAXIS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K782104
510(k) Type
Traditional
Applicant
YOUNG DENTAL MANUFACTURING CO 1, LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/1979
Days to Decision
15 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
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
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
EZX
Mesh, Surgical, Metal
MIB
Elastomer, Silicone Block
MIC
Implant, Muscle, Pectoralis
BTX
Board, Arm (With Cover), Sterile
FTL
Mesh, Surgical, Polymeric
FTM
Mesh, Surgical
FTN
Plastic Surgery And Accessories Kit
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
FWP
Prosthesis, Chin, Internal
FYI
Appliance, Facial Fracture, External
FZD
Prosthesis, Ear, Internal
FZE
Prosthesis, Nose, Internal
K
16
1548
Osseointegrated Fixtures
K
09
0803
HANSON MEDICAL FACIAL IMPLANTS
K
09
0630
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K
07
1018
MONARCH NASAL IMPLANT
K
04
1690
MONARCH NASAL IMPLANT
K
02
1418
AART NASAL IMPLANT
K
99
2242
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
K
98
3755
NASAL DORSAL SERIES
K
98
2753
SEARE BIOMEDICAL NASAL IMPLANTS
K
98
1833
SILIMED NASAL L SHAPED IMPLANT
K
97
3573
DURALASTIC ANATOMICAL NASAL IMPLANTS
K
97
1481
DURALASTIC ANATOMICAL NASAL IMPLANTS
K
96
2824
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
K
96
1124
THE NAUTILUS
K
95
2705
SPIRIT RIDGE NASAL IMPLANT
K
95
2709
PROTHESIS, CHIN, INTERNAL
K
95
2706
SPIRIT RIDGE SILICONE CARVING BLOCK
K
95
2707
SILICONE ELASTOMER MALAR IMPLANT
K
95
2708
PECTORALIS IMPLANT
K
94
5154
BA-CPAS
K
94
1960
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
K
94
2876
IMPLANTECH DORSAL NASAL IMPLANT
K
92
5743
NASAL DORSUM
K
92
5426
RIZZO NASAL IMPLANT
K
92
1580
BRINK PRE-MAXILLARY IMPLANT
K
90
4656
FLOWERS NASAL IMPLANT
K
90
4657
FLOWERS DORSAL COLUMELLA IMPLANT
K
90
4350
CUI DORSAL COLUMELLA PROSTHESIS
K
90
3328
CUI PREMAXILLARY IMPLANT
K
90
2283
THE NAUTILUS NASAL IMPLANT
K
88
0405
SILASTIC NASAL IMPLANT S-TYPE
K
87
1071
OMEGA DORSAL COLUMELLA IMPLANTS
K
86
3942
POREX(TM) NOSE PROSTHESIS
K
86
3430
BYRON BIVALVE NASAL SPLINTS
K
86
3398
BYRON NASAL SEPTAL BUTTON
K
86
3399
BYRON DORSAL COLUMELLA IMPLANT
K
85
3945
CUI RHINOPLASTY IMPLANTS
K
82
2130
FRANCIS NASAL TUBE
K
80
1074
STRAITH NASAL IMPLANT
K
78
2104
PASTE, PRO CARE PROPHYLAXIS
K
78
1574
PLASTI-PORE SEPTAL BUTTON
FZF
Splint, Extremity, Inflatable, External
GBI
Material, External Aesthetic Restoration, Used With Adhesive
GBJ
Prosthesis, Adhesive, External
JCQ
Prosthesis, Esophagus
KCZ
Prosthesis, Breast, External, Used With Adhesive
KDA
Prosthesis, Ptfe/Carbon-Fiber
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
LZK
Implant, Malar
MCA
Tape, Surgical, Internal
MNF
Implant, Temporal
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
NOD
Board, Arm (With Cover), Non-Sterile
NOJ
Prosthesis, Breast, External, No Adhesive
NOK
Material, External Aesthetic Restoration, No Adhesive
NWA
Prosthesis, Tracheal, Preformed/Molded
NYT
Prosthesis, Tracheal, Expandable, Polymeric
ODU
Facial Implant
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
OOD
Surgical Film
OQL
Mesh, Surgical, Deployment Balloon
ORQ
Mesh, Surgical, Deployer
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
OXL
Mesh, Surgical, Absorbable, Organ Support
OXM
Mesh, Surgical, Absorbable, Fistula
OXN
Mesh, Surgical, Collagen, Fistula
PIJ
Collagen Surgical Mesh Containing Drugs
PQN
Carbon Dioxide Gas Controlled Tissue Expander
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-d—prosthetic-devices
/
FZE
/
K782104
View Source
PASTE, PRO CARE PROPHYLAXIS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K782104
510(k) Type
Traditional
Applicant
YOUNG DENTAL MANUFACTURING CO 1, LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/1979
Days to Decision
15 days