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TPLC
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show TPLC since
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2024
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Device
mouthguard, prescription
Product Code
MQC
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
3D DIAGNOSTIX INC.
SUBSTANTIALLY EQUIVALENT
1
ADVANCED FACIALDONTICS LLC
SUBSTANTIALLY EQUIVALENT
1
AMANN GIRRBACH AG
SUBSTANTIALLY EQUIVALENT
1
AMPOWER DENTAL LABORATORIES, LLC
SUBSTANTIALLY EQUIVALENT
1
BELPORT COMPANY, INC., GINGI-PAK
SUBSTANTIALLY EQUIVALENT
1
BERNHARD FÖRSTER GMBH
SUBSTANTIALLY EQUIVALENT
1
BRUX NIGHT GUARD
SUBSTANTIALLY EQUIVALENT
1
DENTONA AG
SUBSTANTIALLY EQUIVALENT
1
DETAX GMBH
SUBSTANTIALLY EQUIVALENT
1
DMG DIGITAL ENTERPRISES SE
SUBSTANTIALLY EQUIVALENT
1
ENVISIONTEC GMBH
SUBSTANTIALLY EQUIVALENT
2
ERKODENT ERICH KOPP GMBH
SUBSTANTIALLY EQUIVALENT
1
FORMLABS OHIO, INC.
SUBSTANTIALLY EQUIVALENT
2
FREY ORAL TECHNOLOGIES LLC
SUBSTANTIALLY EQUIVALENT
1
HKABLE 3D BIOLOGIC PRINTING TECHNOLOGY(CHONGQING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
KEYSTONE INDUSTRIES
SUBSTANTIALLY EQUIVALENT
1
LIJIA LLC
SUBSTANTIALLY EQUIVALENT
1
LUXCREO INC.
SUBSTANTIALLY EQUIVALENT
1
MERIS INVESTMENT GROUP
SUBSTANTIALLY EQUIVALENT
1
MYCONE DENTAL SUPPLY CO. INC. (DBA KEYSTONE INDUSTRIES)
SUBSTANTIALLY EQUIVALENT
1
MYOHEALTH TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
PANTHERA DENTAL INC.
SUBSTANTIALLY EQUIVALENT
1
PRISMATIK DENTALCRAFT, INC.
SUBSTANTIALLY EQUIVALENT
2
PRO3DURE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
PRO3DURE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
2
SLOW WAVE INC.
SUBSTANTIALLY EQUIVALENT
1
SPLINTEK, INC.
SUBSTANTIALLY EQUIVALENT
1
SPRINTRAY INC
SUBSTANTIALLY EQUIVALENT
1
VERTEX-DENTAL BV
SUBSTANTIALLY EQUIVALENT
1
VOCO GMBH
SUBSTANTIALLY EQUIVALENT
1
WHIP MIX CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
62
62
2020
46
46
2021
111
111
2022
137
137
2023
62
62
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
296
296
Insufficient Information
190
190
Patient-Device Incompatibility
4
4
Inadequacy of Device Shape and/or Size
1
1
Device Emits Odor
1
1
Product Quality Problem
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Failure to Osseointegrate
1
1
Loss of Osseointegration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hypersensitivity/Allergic reaction
311
311
Reaction
60
60
Pain
24
24
Swelling
22
22
Burning Sensation
19
19
Swelling/ Edema
18
18
Inflammation
15
15
Discomfort
11
11
Itching Sensation
11
11
Numbness
8
8
Blister
8
8
Rash
7
7
Irritation
7
7
Pressure Sores
5
5
Unspecified Infection
5
5
Ulcer
5
5
Dyspnea
4
4
No Code Available
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Erythema
3
3
Insufficient Information
3
3
Tingling
3
3
Sore Throat
3
3
Local Reaction
2
2
Nausea
2
2
Unspecified Tissue Injury
2
2
Joint Contracture
2
2
Wheal(s)
2
2
Patient Problem/Medical Problem
2
2
Hemorrhage/Bleeding
2
2
Cramp(s) /Muscle Spasm(s)
1
1
Skin Inflammation/ Irritation
1
1
No Information
1
1
Failure of Implant
1
1
Muscular Rigidity
1
1
Peeling
1
1
Encephalitis
1
1
Nasal Obstruction
1
1
Abscess
1
1
Decreased Sensitivity
1
1
Neck Stiffness
1
1
Erosion
1
1
Tinnitus
1
1
Deformity/ Disfigurement
1
1
Sensitivity of Teeth
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Keystone Industries
II
Jan-03-2024
2
Straumann USA LLC
II
Aug-24-2021
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