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LTG
Paste, Injectable For Vocal Cord Augmentation
3
Product Code
LWM
Device, Electrical Dental Anesthesia
U
Product Code
MCL
Kit, Test, In Vitro Periodontal
3
Product Code
MQC
Mouthguard, Prescription
U
Product Code
MVL
Cord, Retraction
U
Product Code
KJJ
Cleanser, Root Canal
U
Product Code
LFD
Saliva, Artificial
U
Product Code
LMW
Solution, Removal, Carries
3
Product Code
LPG
Material, Dressing, Surgical, Polylactic Acid
3
Product Code
LQY
Locator, Root Apex
U
Product Code
K
23
1990
Apex Locator
U
Cleared 510(K)
K
23
2717
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
U
Cleared 510(K)
K
21
2178
Root Apex Locator
U
Cleared 510(K)
K
21
0789
EQ-PEX
U
Cleared 510(K)
K
20
3836
BOMEDENT Apex locator, WISMY Apex locator
U
Cleared 510(K)
K
19
1806
Propex IQ Apex Locator
U
Cleared 510(K)
K
18
1087
Apex Locator, DPEX III
U
Cleared 510(K)
K
17
1867
Dr’s Finder NEO
U
Cleared 510(K)
K
15
1274
Dr's Finder
U
Cleared 510(K)
K
13
1907
RAYPEX 6
U
Cleared 510(K)
K
12
1206
DETECT
U
Cleared 510(K)
K
11
2508
I-ROOT 100
U
Cleared 510(K)
K
11
2153
IROOT 100 MINI
U
Cleared 510(K)
K
11
1474
BINGO PRO
U
Cleared 510(K)
K
10
3123
APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
U
Cleared 510(K)
K
10
0450
I-ROOT
U
Cleared 510(K)
K
10
1177
APEXNRG RIDER
U
Cleared 510(K)
K
10
1054
ROMIAPEX MODEL A-15
U
Cleared 510(K)
K
09
0925
MULTIPLE (APEX LOCATOR), MODEL RCM-7
U
Cleared 510(K)
K
08
3901
NAVI ROOT
U
Cleared 510(K)
K
07
3185
APX21
U
Cleared 510(K)
K
08
0113
APEX DAL ELECTRONIC APEX LOCATOR
U
Cleared 510(K)
K
07
1133
APEXNRG-BLUE ELECTRONIC APEX LOCATOR
U
Cleared 510(K)
K
06
3843
APEXNRG XFR
U
Cleared 510(K)
K
05
3235
NSK PRECISION APEX LOCATOR (PAL)
U
Cleared 510(K)
K
03
2743
APEX NRG
U
Cleared 510(K)
K
03
0895
ASEPTICO ENDOPEX V, MODEL AEU-40
U
Cleared 510(K)
K
02
2147
DENTA PORT
U
Cleared 510(K)
K
02
2020
JUSTWO MODEL TME-601 ROOT APEX LOCATOR
U
Cleared 510(K)
K
00
2195
FORAMATRON V, MODEL D680
U
Cleared 510(K)
K
99
2233
APEX LOCATOR BINGO-1020
U
Cleared 510(K)
K
97
2407
ROOT APEX LOCATOR
U
Cleared 510(K)
K
96
2803
APEX FINDER MODELS 7005
U
Cleared 510(K)
K
96
2853
NEOSONO
U
Cleared 510(K)
K
95
5088
NEOSONO 2000
U
Cleared 510(K)
K
95
3867
ROOT CANAL LENGTH MEASURING DEVICE
U
Cleared 510(K)
K
95
0857
FORAMATRON IV
U
Cleared 510(K)
K
94
5811
PULPDENT CANAL FINDER
U
Cleared 510(K)
K
92
1979
ROOT ZX
U
Cleared 510(K)
K
90
4742
OSADA ENDEX
U
Cleared 510(K)
K
89
0735
COATED APEX PROBE
U
Cleared 510(K)
K
86
3393
ENDOCATER
U
Cleared 510(K)
K
86
4500
ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001
U
Cleared 510(K)
NSJ
Restoration, Noble Metal
N
Product Code
NSK
Dentures, Partial
N
Product Code
NSL
Dentures, Full
N
Product Code
NSM
Restoration, Resin
N
Product Code
NSN
Restoration, Resin, Crown And Bridge
N
Product Code
NSO
Restoration, Porcelain-Fused-To-Metal
N
Product Code
NSP
Restoration, Porcelain
N
Product Code
NSQ
Restoration, Base Metal
N
Product Code
NSR
Prosthesis, Orthodontic
N
Product Code
NXJ
Denture, Cosmetic Only
N
Product Code
OBR
Mouthguard, Over-The-Counter
U
Product Code
OCO
Mouthguard, Migraine/Tension Headache
U
Product Code
OLR
Oral Wound Dressing
U
Product Code
OLS
Oral Wound Dressing W/Drug And/Or Biologic
U
Product Code
PKJ
Crown And Bridge Material, Resin Based
N
Product Code
QUA
Intraoral Cooling Device
2
Product Code
SBC
Dental Image Analyzer
2
Product Code
Submissions with No Product Code
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
Ear, Nose, Throat
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Gastroenterology and Urology
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
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Review Panel
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Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
DE
/
DE-misc
/
LQY
/
K030895
View Source
ASEPTICO ENDOPEX V, MODEL AEU-40
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K030895
510(k) Type
Traditional
Applicant
ASEPTICO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/3/2003
Days to Decision
257 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
LTG
Paste, Injectable For Vocal Cord Augmentation
LWM
Device, Electrical Dental Anesthesia
MCL
Kit, Test, In Vitro Periodontal
MQC
Mouthguard, Prescription
MVL
Cord, Retraction
KJJ
Cleanser, Root Canal
LFD
Saliva, Artificial
LMW
Solution, Removal, Carries
LPG
Material, Dressing, Surgical, Polylactic Acid
LQY
Locator, Root Apex
K
23
1990
Apex Locator
K
23
2717
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K
21
2178
Root Apex Locator
K
21
0789
EQ-PEX
K
20
3836
BOMEDENT Apex locator, WISMY Apex locator
K
19
1806
Propex IQ Apex Locator
K
18
1087
Apex Locator, DPEX III
K
17
1867
Dr’s Finder NEO
K
15
1274
Dr's Finder
K
13
1907
RAYPEX 6
K
12
1206
DETECT
K
11
2508
I-ROOT 100
K
11
2153
IROOT 100 MINI
K
11
1474
BINGO PRO
K
10
3123
APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
K
10
0450
I-ROOT
K
10
1177
APEXNRG RIDER
K
10
1054
ROMIAPEX MODEL A-15
K
09
0925
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K
08
3901
NAVI ROOT
K
07
3185
APX21
K
08
0113
APEX DAL ELECTRONIC APEX LOCATOR
K
07
1133
APEXNRG-BLUE ELECTRONIC APEX LOCATOR
K
06
3843
APEXNRG XFR
K
05
3235
NSK PRECISION APEX LOCATOR (PAL)
K
03
2743
APEX NRG
K
03
0895
ASEPTICO ENDOPEX V, MODEL AEU-40
K
02
2147
DENTA PORT
K
02
2020
JUSTWO MODEL TME-601 ROOT APEX LOCATOR
K
00
2195
FORAMATRON V, MODEL D680
K
99
2233
APEX LOCATOR BINGO-1020
K
97
2407
ROOT APEX LOCATOR
K
96
2803
APEX FINDER MODELS 7005
K
96
2853
NEOSONO
K
95
5088
NEOSONO 2000
K
95
3867
ROOT CANAL LENGTH MEASURING DEVICE
K
95
0857
FORAMATRON IV
K
94
5811
PULPDENT CANAL FINDER
K
92
1979
ROOT ZX
K
90
4742
OSADA ENDEX
K
89
0735
COATED APEX PROBE
K
86
3393
ENDOCATER
K
86
4500
ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001
NSJ
Restoration, Noble Metal
NSK
Dentures, Partial
NSL
Dentures, Full
NSM
Restoration, Resin
NSN
Restoration, Resin, Crown And Bridge
NSO
Restoration, Porcelain-Fused-To-Metal
NSP
Restoration, Porcelain
NSQ
Restoration, Base Metal
NSR
Prosthesis, Orthodontic
NXJ
Denture, Cosmetic Only
OBR
Mouthguard, Over-The-Counter
OCO
Mouthguard, Migraine/Tension Headache
OLR
Oral Wound Dressing
OLS
Oral Wound Dressing W/Drug And/Or Biologic
PKJ
Crown And Bridge Material, Resin Based
QUA
Intraoral Cooling Device
SBC
Dental Image Analyzer
Submissions with No Product Code
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
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
/
DE-misc
/
LQY
/
K030895
View Source
ASEPTICO ENDOPEX V, MODEL AEU-40
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K030895
510(k) Type
Traditional
Applicant
ASEPTICO, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/3/2003
Days to Decision
257 days
Submission Type
Summary