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Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
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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
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
DYJ
Retainer, Screw Expansion, Orthodontic
1
Product Code
DYO
Band, Material, Orthodontic
1
Product Code
DYT
Maintainer, Space Preformed, Orthodontic
1
Product Code
DYW
Bracket, Plastic, Orthodontic
2
Product Code
DZB
Headgear, Extraoral, Orthodontic
2
Product Code
DZC
Wire, Orthodontic
1
Product Code
DZD
Tube, Orthodontic
1
Product Code
ECI
Band, Elastic, Orthodontic
1
Product Code
ECM
Band, Preformed, Orthodontic
1
Product Code
ECN
Clamp, Wire, Orthodontic
1
Product Code
ECO
Spring, Orthodontic
1
Product Code
EJF
Bracket, Metal, Orthodontic
1
Product Code
KKO
Ring, Teething, Fluid-Filled
2
Product Code
K
12
3855
WATER-FILLED TEETHER
2
Cleared 510(K)
K
11
0615
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
2
Cleared 510(K)
K
09
2025
FLUID FILLED TEETHER - GEL
2
Cleared 510(K)
K
09
3266
MAM COOLER
2
Cleared 510(K)
K
09
2781
MAM TWISTER
2
Cleared 510(K)
K
09
2494
GEL FILLED GUM SOOTHER
2
Cleared 510(K)
K
09
3370
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
2
Cleared 510(K)
K
09
2910
FLUID-FILLED TEETHER
2
Cleared 510(K)
K
09
1198
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
2
Cleared 510(K)
K
09
0167
PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,
2
Cleared 510(K)
K
08
2824
FLUID FILLED TEETHER
2
Cleared 510(K)
K
08
3512
FLUID-FILLED TEETHER
2
Cleared 510(K)
K
07
2082
GUMEASE DENTAL MOUTHPIECE
2
Cleared 510(K)
K
05
2513
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
2
Cleared 510(K)
K
05
3493
BERRY FRUITY TEETHER
2
Cleared 510(K)
K
05
2531
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
2
Cleared 510(K)
K
05
2105
WATER FILLED TEETHER
2
Cleared 510(K)
K
04
3033
GLOBAL TREASURES FLUID FILLED TEETHER
2
Cleared 510(K)
K
03
1094
FLUID FILLED TEETHERS
2
Cleared 510(K)
K
01
4023
BABY TEETHER, MODEL 20104
2
Cleared 510(K)
K
01
3587
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
2
Cleared 510(K)
K
00
2066
FREEZER TEETHER
2
Cleared 510(K)
K
98
1202
WATER FILLED GUM SOOTHER
2
Cleared 510(K)
K
96
5082
SOOTHING WATER-FILLED TEETHER
2
Cleared 510(K)
K
96
3912
TYCO BABY SESAME STREET SOFT TEETHER
2
Cleared 510(K)
K
95
5069
PLAYSKOOL
2
Cleared 510(K)
K
90
2974
COOLING TEETHERS
2
Cleared 510(K)
KMY
Positioner, Tooth, Preformed
1
Product Code
LQZ
Device, Jaw Repositioning
2
Product Code
LRK
Device, Anti-Snoring
2
Product Code
LTF
Stimulator, Salivary System
2
Product Code
MEF
Ring, Teething, Non-Fluid Filled
1
Product Code
NJM
Bracket, Ceramic, Orthodontic
2
Product Code
NLC
Bracket, Plastic, Orthodontic, Reprocessed
2
Product Code
NQS
Bracket, Metal, Orthodontic, Reprocessed
1
Product Code
NTO
Rinse, Oral, Antibacterial (By Physical Means)
2
Product Code
NXC
Aligner, Sequential
2
Product Code
PLC
Sleep Appliances With Patient Monitoring
2
Product Code
OHP
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
2
Product Code
ORY
Prelude Tongue Suspension System
2
Product Code
OYH
Orthodontic Vibratory Accessory
2
Product Code
PLH
Orthodontic Led Accessory
2
Product Code
PNN
Orthodontic Software
2
Product Code
QCJ
Closed Loop Auto Titration Device For Oral Appliances
2
Product Code
QJJ
Indirect Bonding Tray
1
Product Code
QNO
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
2
Product Code
QTT
Over The Counter Electrical Salivary Stimulatory System
2
Product Code
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 20 December 2024 at 11:05 pm
DE
/
subpart-f—therapeutic-devices
/
KKO
/
K014023
View Source
BABY TEETHER, MODEL 20104
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K014023
510(k) Type
Traditional
Applicant
ANGELINA TRADING, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/2/2002
Days to Decision
239 days
Submission Type
Statement
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
DYJ
Retainer, Screw Expansion, Orthodontic
DYO
Band, Material, Orthodontic
DYT
Maintainer, Space Preformed, Orthodontic
DYW
Bracket, Plastic, Orthodontic
DZB
Headgear, Extraoral, Orthodontic
DZC
Wire, Orthodontic
DZD
Tube, Orthodontic
ECI
Band, Elastic, Orthodontic
ECM
Band, Preformed, Orthodontic
ECN
Clamp, Wire, Orthodontic
ECO
Spring, Orthodontic
EJF
Bracket, Metal, Orthodontic
KKO
Ring, Teething, Fluid-Filled
K
12
3855
WATER-FILLED TEETHER
K
11
0615
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
K
09
2025
FLUID FILLED TEETHER - GEL
K
09
3266
MAM COOLER
K
09
2781
MAM TWISTER
K
09
2494
GEL FILLED GUM SOOTHER
K
09
3370
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
K
09
2910
FLUID-FILLED TEETHER
K
09
1198
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
K
09
0167
PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,
K
08
2824
FLUID FILLED TEETHER
K
08
3512
FLUID-FILLED TEETHER
K
07
2082
GUMEASE DENTAL MOUTHPIECE
K
05
2513
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
K
05
3493
BERRY FRUITY TEETHER
K
05
2531
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
K
05
2105
WATER FILLED TEETHER
K
04
3033
GLOBAL TREASURES FLUID FILLED TEETHER
K
03
1094
FLUID FILLED TEETHERS
K
01
4023
BABY TEETHER, MODEL 20104
K
01
3587
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
K
00
2066
FREEZER TEETHER
K
98
1202
WATER FILLED GUM SOOTHER
K
96
5082
SOOTHING WATER-FILLED TEETHER
K
96
3912
TYCO BABY SESAME STREET SOFT TEETHER
K
95
5069
PLAYSKOOL
K
90
2974
COOLING TEETHERS
KMY
Positioner, Tooth, Preformed
LQZ
Device, Jaw Repositioning
LRK
Device, Anti-Snoring
LTF
Stimulator, Salivary System
MEF
Ring, Teething, Non-Fluid Filled
NJM
Bracket, Ceramic, Orthodontic
NLC
Bracket, Plastic, Orthodontic, Reprocessed
NQS
Bracket, Metal, Orthodontic, Reprocessed
NTO
Rinse, Oral, Antibacterial (By Physical Means)
NXC
Aligner, Sequential
PLC
Sleep Appliances With Patient Monitoring
OHP
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
ORY
Prelude Tongue Suspension System
OYH
Orthodontic Vibratory Accessory
PLH
Orthodontic Led Accessory
PNN
Orthodontic Software
QCJ
Closed Loop Auto Titration Device For Oral Appliances
QJJ
Indirect Bonding Tray
QNO
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
QTT
Over The Counter Electrical Salivary Stimulatory System
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-f—therapeutic-devices
/
KKO
/
K014023
View Source
BABY TEETHER, MODEL 20104
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K014023
510(k) Type
Traditional
Applicant
ANGELINA TRADING, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/2/2002
Days to Decision
239 days
Submission Type
Statement