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Review Panel
Cardiovascular
Review Panel
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Review Panel
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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
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
EAQ
Detector, Ultraviolet
2
Product Code
DYN
Mouthpiece, Saliva Ejector
1
Product Code
EBR
Unit, Suction Operatory
1
Product Code
EBZ
Activator, Ultraviolet, For Polymerization
2
Product Code
ECC
Sterilizer, Glass Bead
3
Product Code
ECG
Sterilizer, Boiling Water
1
Product Code
EEA
Plate, Base, Shellac
1
Product Code
EEF
Clamp, Rubber Dam
1
Product Code
EEG
Heat Source For Bleaching Teeth
1
Product Code
EEJ
Guard, Disk
1
Product Code
EFC
Warmer, Anesthetic Tube
1
Product Code
EFH
Paper, Articulation
1
Product Code
EFN
Cotton, Roll
1
Product Code
EFS
Unit, Oral Irrigation
1
Product Code
EFW
Toothbrush, Manual
1
Product Code
EFX
Protector, Silicate
1
Product Code
EGD
Wax, Dental, Intraoral
1
Product Code
EHJ
Disk, Abrasive
1
Product Code
EHK
Cup, Prophylaxis
1
Product Code
EHL
Point, Abrasive
1
Product Code
EHM
Strip, Polishing Agent
1
Product Code
EHY
Tray, Impression, Preformed
1
Product Code
EHZ
Evacuator, Oral Cavity
1
Product Code
EIA
Unit, Operative Dental
1
Product Code
EIE
Dam, Rubber
1
Product Code
EIH
Powder, Porcelain
2
Product Code
EJE
Frame, Rubber Dam
1
Product Code
EJG
Forceps, Rubber Dam Clamp
1
Product Code
EJI
Syringe, Cartridge
2
Product Code
EJQ
Wheel, Polishing Agent
1
Product Code
EJR
Agent, Polishing, Abrasive, Oral Cavity
1
Product Code
JEQ
Toothbrush, Powered
1
Product Code
JES
Floss, Dental
1
Product Code
JET
Pick, Massaging
1
Product Code
JEW
Tip, Rubber, Oral Hygiene
1
Product Code
KCQ
Tube Impression And Matrix
1
Product Code
KHR
Absorber, Saliva, Paper
1
Product Code
KLC
Chair, Dental, With Operative Unit
1
Product Code
K
23
3921
Luvis Chair (LC700C)
1
Cleared 510(K)
K
15
1987
DCI Edge Dental Chair with Operative Unit
1
Cleared 510(K)
K
07
1353
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
1
Cleared 510(K)
K
97
1063
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
1
Cleared 510(K)
K
96
3209
PROSTYLE COMPACT
1
Cleared 510(K)
K
94
2870
ULTIMA 2 DENTAL CHAIR
1
Cleared 510(K)
K
94
0950
KAVO SYSTEMATICA 1060
1
Cleared 510(K)
K
92
5567
E 4000 DENTAL OPERATING CHAIR
1
Cleared 510(K)
K
92
5119
A-DEC 1040 CHAIR
1
Cleared 510(K)
K
92
3534
PM2002 PROLINE
1
Cleared 510(K)
K
92
5322
A-DEC 2147 DOCTOR'S UNIT
1
Cleared 510(K)
K
92
5321
A-DEC 2146 DUO UNIT
1
Cleared 510(K)
K
92
5319
A-DEC 2182 DOCTOR'S UNIT
1
Cleared 510(K)
K
92
5318
A-DEC 2181 DUO UNIT
1
Cleared 510(K)
K
92
5317
A-DEC 2180 DUO UNIT, CUSP
1
Cleared 510(K)
K
92
5316
A-DEC 2172 DOCTOR'S UNIT
1
Cleared 510(K)
K
92
5315
A-DEC 2171 DUO UNIT
1
Cleared 510(K)
K
92
5314
A-DEC 2170 DUO UNIT CUSP
1
Cleared 510(K)
K
92
5320
A-DEC 2145 DUO UNIT, CUSP
1
Cleared 510(K)
K
92
5325
A-DEC 2185 DOCTOR'S UNIT
1
Cleared 510(K)
K
92
5324
A-DEC 2184 DUO UNIT
1
Cleared 510(K)
K
92
5323
A-DEC 2183 DUO UNIT, CUSP
1
Cleared 510(K)
K
93
1169
MDT DENTAL CHAIR
1
Cleared 510(K)
K
92
3461
PM2002 PROLINE, PM2002 PROLINE EC
1
Cleared 510(K)
K
92
2175
HEALTHPAK CHAIR SOX BARRIERS
1
Cleared 510(K)
K
92
3306
HEALTHPAK UTILITY SOX BARRIERS
1
Cleared 510(K)
K
92
0017
IMPROVED DENTAL OPERATING LIGHT
1
Cleared 510(K)
K
92
0016
IMPROVED DENTAL CHAIR
1
Cleared 510(K)
K
91
3535
A-DEC DECADE 1020 CHAIR
1
Cleared 510(K)
K
91
3059
A-DEC KNEEBREAK 1030 CHAIR
1
Cleared 510(K)
K
90
3450
A-DEC DECADE 1015 CHAIR
1
Cleared 510(K)
K
90
3454
A-DEC DECADE 1010 CHAIR
1
Cleared 510(K)
K
89
6602
FD5000 DENTAL CHAIR
1
Cleared 510(K)
K
89
4060
ESSE QUATTRO/ESSE UNO
1
Cleared 510(K)
K
89
3943
FD 200 DENTAL STOOL
1
Cleared 510(K)
K
89
3944
FD 300 DENTAL STOOL
1
Cleared 510(K)
K
89
3889
FD3500 (DENTAL CHAIR)
1
Cleared 510(K)
K
89
3890
FD4500 (DENTAL CHAIR)
1
Cleared 510(K)
K
89
3945
FD 350 DENTAL STOOL
1
Cleared 510(K)
K
89
3946
FD 400 DENTAL STOOL
1
Cleared 510(K)
K
89
3454
CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD
1
Cleared 510(K)
K
89
3045
A-DEC PRIORITY 1005 CHAIR
1
Cleared 510(K)
K
88
4304
ORTHO PATIENT CHAIR
1
Cleared 510(K)
K
88
4830
DENTAL CHAIR F1
1
Cleared 510(K)
K
88
3437
DENTAL CHAIR
1
Cleared 510(K)
K
88
0474
AREA (DENTAL CHAIR)
1
Cleared 510(K)
K
88
0475
SKEMA (DENTAL UNIT)
1
Cleared 510(K)
K
86
3016
DENTATUS L SET
1
Cleared 510(K)
K
86
3484
SIEMENS SIRONA(R) DENTAL CHAIR
1
Cleared 510(K)
K
85
4647
POLO DENTAL UNIT
1
Cleared 510(K)
K
85
4644
MANTA DENTAL CHAIR
1
Cleared 510(K)
K
84
3233
ANATOM SYSTEM
1
Cleared 510(K)
K
84
3436
DENTAL CHAIR
1
Cleared 510(K)
K
82
2095
HERPES-IHA KIT
1
Cleared 510(K)
K
82
2740
K30000 DENTAL CHAIR
1
Cleared 510(K)
K
80
0276
RITTER MODEL H COMPANION STOOL
1
Cleared 510(K)
K
80
0172
SIROPORT
1
Cleared 510(K)
K
80
0084
RITTER MODEL J DENTAL CHAIR
1
Cleared 510(K)
K
77
2300
DENTAL CHAIR, VANGUARD
1
Cleared 510(K)
K
77
1873
VISION SERIES DENTAL CHAIR
1
Cleared 510(K)
K
76
0599
DENTAL CHAIRS
1
Cleared 510(K)
K
76
0404
BI-CENTRIC SYSTEM
1
Cleared 510(K)
K
76
0322
CHAIR, ATTACHED INSTRUMENT DEL. SYS.
1
Cleared 510(K)
KMT
Tray, Fluoride, Disposable
1
Product Code
KOJ
Airbrush
2
Product Code
KOK
Sterilizer, Endodontic Dry Heat
3
Product Code
LCN
Scraper, Tongue
1
Product Code
MAU
Eraser, Dental Stain
1
Product Code
MCF
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
1
Product Code
MMD
Toothbrush, Ionic, Battery-Powered
1
Product Code
NOB
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
1
Product Code
NRD
Unit, Operative Dental, Accessories
1
Product Code
NRU
Chair, Dental, Without Operative Unit
1
Product Code
NXV
Diagnostic Light, Soft Tissue Detector
2
Product Code
NXZ
Dental Hygiene Kit
1
Product Code
PIP
Prophy Powder, Airbrush Accessory
2
Product Code
OFX
General Purpose Dental Tray
1
Product Code
PFL
Intraoral, Dental Foam Protector
1
Product Code
QGO
Composite Resin Warmer
1
Product Code
QIA
Powered Tongue Scraper
1
Product Code
QJC
Plaque Disclosing Agent
1
Product Code
QMJ
Powered Radiofrequency Toothbrush
2
Product Code
QNF
Laser Activator For Polymerization
2
Product Code
QYJ
Dental Waterline Treatment Cartridge
1
Product Code
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
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Last synced on 6 December 2024 at 11:05 pm
DE
/
subpart-g—miscellaneous-devices
/
KLC
/
K903450
View Source
A-DEC DECADE 1015 CHAIR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K903450
510(k) Type
Traditional
Applicant
A-DEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/1990
Days to Decision
85 days
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
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
EAQ
Detector, Ultraviolet
DYN
Mouthpiece, Saliva Ejector
EBR
Unit, Suction Operatory
EBZ
Activator, Ultraviolet, For Polymerization
ECC
Sterilizer, Glass Bead
ECG
Sterilizer, Boiling Water
EEA
Plate, Base, Shellac
EEF
Clamp, Rubber Dam
EEG
Heat Source For Bleaching Teeth
EEJ
Guard, Disk
EFC
Warmer, Anesthetic Tube
EFH
Paper, Articulation
EFN
Cotton, Roll
EFS
Unit, Oral Irrigation
EFW
Toothbrush, Manual
EFX
Protector, Silicate
EGD
Wax, Dental, Intraoral
EHJ
Disk, Abrasive
EHK
Cup, Prophylaxis
EHL
Point, Abrasive
EHM
Strip, Polishing Agent
EHY
Tray, Impression, Preformed
EHZ
Evacuator, Oral Cavity
EIA
Unit, Operative Dental
EIE
Dam, Rubber
EIH
Powder, Porcelain
EJE
Frame, Rubber Dam
EJG
Forceps, Rubber Dam Clamp
EJI
Syringe, Cartridge
EJQ
Wheel, Polishing Agent
EJR
Agent, Polishing, Abrasive, Oral Cavity
JEQ
Toothbrush, Powered
JES
Floss, Dental
JET
Pick, Massaging
JEW
Tip, Rubber, Oral Hygiene
KCQ
Tube Impression And Matrix
KHR
Absorber, Saliva, Paper
KLC
Chair, Dental, With Operative Unit
K
23
3921
Luvis Chair (LC700C)
K
15
1987
DCI Edge Dental Chair with Operative Unit
K
07
1353
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
K
97
1063
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR
K
96
3209
PROSTYLE COMPACT
K
94
2870
ULTIMA 2 DENTAL CHAIR
K
94
0950
KAVO SYSTEMATICA 1060
K
92
5567
E 4000 DENTAL OPERATING CHAIR
K
92
5119
A-DEC 1040 CHAIR
K
92
3534
PM2002 PROLINE
K
92
5322
A-DEC 2147 DOCTOR'S UNIT
K
92
5321
A-DEC 2146 DUO UNIT
K
92
5319
A-DEC 2182 DOCTOR'S UNIT
K
92
5318
A-DEC 2181 DUO UNIT
K
92
5317
A-DEC 2180 DUO UNIT, CUSP
K
92
5316
A-DEC 2172 DOCTOR'S UNIT
K
92
5315
A-DEC 2171 DUO UNIT
K
92
5314
A-DEC 2170 DUO UNIT CUSP
K
92
5320
A-DEC 2145 DUO UNIT, CUSP
K
92
5325
A-DEC 2185 DOCTOR'S UNIT
K
92
5324
A-DEC 2184 DUO UNIT
K
92
5323
A-DEC 2183 DUO UNIT, CUSP
K
93
1169
MDT DENTAL CHAIR
K
92
3461
PM2002 PROLINE, PM2002 PROLINE EC
K
92
2175
HEALTHPAK CHAIR SOX BARRIERS
K
92
3306
HEALTHPAK UTILITY SOX BARRIERS
K
92
0017
IMPROVED DENTAL OPERATING LIGHT
K
92
0016
IMPROVED DENTAL CHAIR
K
91
3535
A-DEC DECADE 1020 CHAIR
K
91
3059
A-DEC KNEEBREAK 1030 CHAIR
K
90
3450
A-DEC DECADE 1015 CHAIR
K
90
3454
A-DEC DECADE 1010 CHAIR
K
89
6602
FD5000 DENTAL CHAIR
K
89
4060
ESSE QUATTRO/ESSE UNO
K
89
3943
FD 200 DENTAL STOOL
K
89
3944
FD 300 DENTAL STOOL
K
89
3889
FD3500 (DENTAL CHAIR)
K
89
3890
FD4500 (DENTAL CHAIR)
K
89
3945
FD 350 DENTAL STOOL
K
89
3946
FD 400 DENTAL STOOL
K
89
3454
CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD
K
89
3045
A-DEC PRIORITY 1005 CHAIR
K
88
4304
ORTHO PATIENT CHAIR
K
88
4830
DENTAL CHAIR F1
K
88
3437
DENTAL CHAIR
K
88
0474
AREA (DENTAL CHAIR)
K
88
0475
SKEMA (DENTAL UNIT)
K
86
3016
DENTATUS L SET
K
86
3484
SIEMENS SIRONA(R) DENTAL CHAIR
K
85
4647
POLO DENTAL UNIT
K
85
4644
MANTA DENTAL CHAIR
K
84
3233
ANATOM SYSTEM
K
84
3436
DENTAL CHAIR
K
82
2095
HERPES-IHA KIT
K
82
2740
K30000 DENTAL CHAIR
K
80
0276
RITTER MODEL H COMPANION STOOL
K
80
0172
SIROPORT
K
80
0084
RITTER MODEL J DENTAL CHAIR
K
77
2300
DENTAL CHAIR, VANGUARD
K
77
1873
VISION SERIES DENTAL CHAIR
K
76
0599
DENTAL CHAIRS
K
76
0404
BI-CENTRIC SYSTEM
K
76
0322
CHAIR, ATTACHED INSTRUMENT DEL. SYS.
KMT
Tray, Fluoride, Disposable
KOJ
Airbrush
KOK
Sterilizer, Endodontic Dry Heat
LCN
Scraper, Tongue
MAU
Eraser, Dental Stain
MCF
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
MMD
Toothbrush, Ionic, Battery-Powered
NOB
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
NRD
Unit, Operative Dental, Accessories
NRU
Chair, Dental, Without Operative Unit
NXV
Diagnostic Light, Soft Tissue Detector
NXZ
Dental Hygiene Kit
PIP
Prophy Powder, Airbrush Accessory
OFX
General Purpose Dental Tray
PFL
Intraoral, Dental Foam Protector
QGO
Composite Resin Warmer
QIA
Powered Tongue Scraper
QJC
Plaque Disclosing Agent
QMJ
Powered Radiofrequency Toothbrush
QNF
Laser Activator For Polymerization
QYJ
Dental Waterline Treatment Cartridge
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-g—miscellaneous-devices
/
KLC
/
K903450
View Source
A-DEC DECADE 1015 CHAIR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K903450
510(k) Type
Traditional
Applicant
A-DEC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/1990
Days to Decision
85 days