FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
Miscellaneous
Miscellaneous
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
K
24
1369
LIJIA Night Guard
U
Cleared 510(K)
K
23
1775
GR Resin System MSI
U
Cleared 510(K)
K
24
1311
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
U
Cleared 510(K)
K
24
0463
Slow Wave DS8 (SWDS802)
U
Cleared 510(K)
K
23
1793
RODIN 3D Resin SPLINT, Hard/Flex
U
Cleared 510(K)
K
23
2087
Dental LT Comfort Resin
U
Cleared 510(K)
K
23
0548
Myoaligner Appliance
U
Cleared 510(K)
K
23
0592
LuxCreo Dental Night Guard Resin
U
Cleared 510(K)
K
22
2845
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
U
Cleared 510(K)
K
23
0495
Serena Sleep Night Guard
U
Cleared 510(K)
K
23
2448
FREEPRINT® splintmaster
U
Cleared 510(K)
K
23
0237
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
U
Cleared 510(K)
K
22
2604
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
U
Cleared 510(K)
K
22
3798
Glidewell TuffSplint™ Appliance Resin
U
Cleared 510(K)
K
22
2061
Dental LT Clear V2 Resin
U
Cleared 510(K)
K
22
1022
NextDent Ortho Flex
U
Cleared 510(K)
K
22
0894
SmileGuard
U
Cleared 510(K)
K
21
2017
Thermeo System
U
Cleared 510(K)
K
21
4102
Glidewell Appliance Resin, Hard/Soft
U
Cleared 510(K)
K
21
2767
SleepRight Select-Comfort Dental Guard
U
Cleared 510(K)
K
21
2448
NightGuard Flex
U
Cleared 510(K)
K
21
1415
GR Splint Resin System
U
Cleared 510(K)
K
21
0940
LuxaPrint Ortho Plus
U
Cleared 510(K)
K
21
0011
JS Dental Lab Mouth Guard
U
Cleared 510(K)
K
20
3596
Panthera Occlusal Appliance
U
Cleared 510(K)
K
20
3000
KeyPrint KeySplint Hard
U
Cleared 510(K)
K
20
1173
E-Guard
U
Cleared 510(K)
K
20
2465
Night Guard
U
Cleared 510(K)
K
20
1091
V-Print splint
U
Cleared 510(K)
K
20
0125
Thermoforming Sheet Materials
U
Cleared 510(K)
K
19
1836
Ceramill A-Splint
U
Cleared 510(K)
K
18
3598
KeyPrint KeySplint Soft
U
Cleared 510(K)
K
18
2820
The POD
U
Cleared 510(K)
K
19
0107
VeriSplint
U
Cleared 510(K)
K
18
1361
Brux Night Guard
U
Cleared 510(K)
K
17
0985
Urbanek Device
U
Cleared 510(K)
K
16
1884
Ortho System
U
Cleared 510(K)
K
15
1933
BRX PRO Bruxism Guard
U
Cleared 510(K)
K
14
3655
SICAT OPTIMOTION
U
Cleared 510(K)
K
14
3623
Narval Brux
U
Cleared 510(K)
K
13
4015
M-PM-DISC
U
Cleared 510(K)
K
12
3161
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
U
Cleared 510(K)
K
12
1365
THERMOFORMED MOUTHGUARDS
U
Cleared 510(K)
K
11
2868
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
U
Cleared 510(K)
K
10
2909
SOMNOBRUX SPLINTS
U
Cleared 510(K)
K
11
1066
MIGRA TAB, QUICKSPLINT MIGRAINE
U
Cleared 510(K)
K
11
1828
CLEARSPLINT ES
U
Cleared 510(K)
K
11
0468
FREEWAY COMFORT BITE GUARD
U
Cleared 510(K)
K
09
1880
CLAYTON INTRA-AURAL DEVICE (CID)
U
Cleared 510(K)
K
09
0472
GRIND GUARD
U
Cleared 510(K)
K
08
2723
GRINDGUARD
U
Cleared 510(K)
K
07
2522
THERMOFORM SHEET MATERIALS AND ACCESSORIES
U
Cleared 510(K)
K
07
1404
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
U
Cleared 510(K)
K
06
1122
NIGHT GUARD
U
Cleared 510(K)
K
06
3483
DEN TEK NIGHTGUARD
U
Cleared 510(K)
K
06
2828
MOUTHGUARD AND ALIGNER MATERIALS
U
Cleared 510(K)
K
05
3580
DOCTOR'S NIGHTGUARD
U
Cleared 510(K)
K
04
0315
MYOHEALTH CLENCHING INHIBITOR
U
Cleared 510(K)
K
02
2809
EZ SPLINT & EZ SPLINT PM
U
Cleared 510(K)
K
03
0832
PRIMOSPLINT SYSTEM
U
Cleared 510(K)
K
02
4261
DENTAL PROTECTOR
U
Cleared 510(K)
K
02
2627
DSG RELAXER SPLINT
U
Cleared 510(K)
K
01
4079
DR. HAYS BITE GUARD
U
Cleared 510(K)
K
98
0953
ACCU-BITE HOME KIT DISCLUDER
U
Cleared 510(K)
K
98
1546
NTI CLENCHING SUPPRESSION SYSTEM
U
Cleared 510(K)
K
95
5701
NIGHTGUARD DIAGNOSTIC APPLIANCE
U
Cleared 510(K)
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
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
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
/
DE-misc
/
MQC
/
K134015
View Source
M-PM-DISC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K134015
510(k) Type
Traditional
Applicant
MERZ DENTAL GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/11/2014
Days to Decision
105 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
K
24
1369
LIJIA Night Guard
K
23
1775
GR Resin System MSI
K
24
1311
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
K
24
0463
Slow Wave DS8 (SWDS802)
K
23
1793
RODIN 3D Resin SPLINT, Hard/Flex
K
23
2087
Dental LT Comfort Resin
K
23
0548
Myoaligner Appliance
K
23
0592
LuxCreo Dental Night Guard Resin
K
22
2845
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
K
23
0495
Serena Sleep Night Guard
K
23
2448
FREEPRINT® splintmaster
K
23
0237
Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
K
22
2604
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
K
22
3798
Glidewell TuffSplint™ Appliance Resin
K
22
2061
Dental LT Clear V2 Resin
K
22
1022
NextDent Ortho Flex
K
22
0894
SmileGuard
K
21
2017
Thermeo System
K
21
4102
Glidewell Appliance Resin, Hard/Soft
K
21
2767
SleepRight Select-Comfort Dental Guard
K
21
2448
NightGuard Flex
K
21
1415
GR Splint Resin System
K
21
0940
LuxaPrint Ortho Plus
K
21
0011
JS Dental Lab Mouth Guard
K
20
3596
Panthera Occlusal Appliance
K
20
3000
KeyPrint KeySplint Hard
K
20
1173
E-Guard
K
20
2465
Night Guard
K
20
1091
V-Print splint
K
20
0125
Thermoforming Sheet Materials
K
19
1836
Ceramill A-Splint
K
18
3598
KeyPrint KeySplint Soft
K
18
2820
The POD
K
19
0107
VeriSplint
K
18
1361
Brux Night Guard
K
17
0985
Urbanek Device
K
16
1884
Ortho System
K
15
1933
BRX PRO Bruxism Guard
K
14
3655
SICAT OPTIMOTION
K
14
3623
Narval Brux
K
13
4015
M-PM-DISC
K
12
3161
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
K
12
1365
THERMOFORMED MOUTHGUARDS
K
11
2868
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
K
10
2909
SOMNOBRUX SPLINTS
K
11
1066
MIGRA TAB, QUICKSPLINT MIGRAINE
K
11
1828
CLEARSPLINT ES
K
11
0468
FREEWAY COMFORT BITE GUARD
K
09
1880
CLAYTON INTRA-AURAL DEVICE (CID)
K
09
0472
GRIND GUARD
K
08
2723
GRINDGUARD
K
07
2522
THERMOFORM SHEET MATERIALS AND ACCESSORIES
K
07
1404
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
K
06
1122
NIGHT GUARD
K
06
3483
DEN TEK NIGHTGUARD
K
06
2828
MOUTHGUARD AND ALIGNER MATERIALS
K
05
3580
DOCTOR'S NIGHTGUARD
K
04
0315
MYOHEALTH CLENCHING INHIBITOR
K
02
2809
EZ SPLINT & EZ SPLINT PM
K
03
0832
PRIMOSPLINT SYSTEM
K
02
4261
DENTAL PROTECTOR
K
02
2627
DSG RELAXER SPLINT
K
01
4079
DR. HAYS BITE GUARD
K
98
0953
ACCU-BITE HOME KIT DISCLUDER
K
98
1546
NTI CLENCHING SUPPRESSION SYSTEM
K
95
5701
NIGHTGUARD DIAGNOSTIC APPLIANCE
MVL
Cord, Retraction
KJJ
Cleanser, Root Canal
LFD
Saliva, Artificial
LMW
Solution, Removal, Carries
LPG
Material, Dressing, Surgical, Polylactic Acid
LQY
Locator, Root Apex
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
/
MQC
/
K134015
View Source
M-PM-DISC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K134015
510(k) Type
Traditional
Applicant
MERZ DENTAL GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/11/2014
Days to Decision
105 days
Submission Type
Summary