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Found 68 results
510(k) Data Aggregation
K Number
K241729Device Name
Hard Splint & Thermo-Adaptive Splint
Manufacturer
Whip Mix Corporation
Date Cleared
2025-03-18
(277 days)
Product Code
MQC, KMY
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Device Description
Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers.
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K Number
K243516Device Name
Remi Custom Night Guard
Manufacturer
GrindGuard Inc
Date Cleared
2025-02-10
(89 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Remi Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
Device Description
The Remi Custom Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
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K Number
K241369Device Name
LIJIA Night Guard
Manufacturer
Lijia LLC
Date Cleared
2024-08-22
(100 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LIJIA Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
Device Description
The LIJIA Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
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K Number
K231775Device Name
GR Resin System MSI
Manufacturer
Pro3dure Medical
Date Cleared
2024-08-08
(419 days)
Product Code
MQC, KMY
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The printodent® GR-10 guide | MSI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.
The printodent® GR-19.1 OA is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
Device Description
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
GR-10 guide MSI is made of functional methacrylic resins and inorganic fillers and the GR-19.1 OA, and GR-19.1 OA MSI consist of functional (meth)acrylic resins, initiators, dyes, stabilisers and lactam.
The GR-10 guide MSI, and GR-19.1 OA MSI are available in ocean blue shade, and the GR-19.1 OA is available in clear transparent. The resin is a liquid photo-curable material that is polymerized by image projection systems at ≤ 405 nm to create dental appliances. The GR Resin System MSI is intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems
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K Number
K241311Device Name
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
Manufacturer
Bernhard Förster GmbH
Date Cleared
2024-08-02
(85 days)
Product Code
MQC, MOC
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermoforming Sheet Materials Track A, B, E and Bleach are indication of orthodontic and dental appliances.
Device Description
Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patient individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. Thermoforming Sheet Materials include the following products: Thermoforming Sheet Materials: Track A, Track B, Track E, Track bleach.
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K Number
K240463Device Name
Slow Wave DS8 (SWDS802)
Manufacturer
Slow Wave Inc.
Date Cleared
2024-06-04
(109 days)
Product Code
MQC, OCO
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Slow Wave DS8 is indicated for the treatment of sleep bruxism and as an aid in the treatment of associated tension/migraine type headaches in adults over the age of 18.
Device Description
The Slow Wave DS8 is an intraoral appliance designed to safeguard teeth and restorations from the impacts of bruxism forces. It is a patient-specific device that consists of two trays worn on the maxilla and mandible conforming to the upper or lower teeth. This device acts as a physical divide between upper and lower tooth surfaces, preventing damage induced by bruxism activities such as grinding and clenching. Additionally, it eases discomfort associated with muscle tension and headaches. Multiple tray designs are available for this purpose, each offering distinct levels of functionality and suitability based on the patient's requirements. The device is manufactured using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
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K Number
K231793Device Name
RODIN 3D Resin SPLINT, Hard/Flex
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2024-03-26
(280 days)
Product Code
MQC, KMY
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RODIN Splint is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints and repositioners.
Device Description
Not Found
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K Number
K232087Device Name
Dental LT Comfort Resin
Manufacturer
Formlabs Ohio, Inc.
Date Cleared
2024-02-16
(218 days)
Product Code
MQC, CLA, KMY
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental LT Comfort Resin when utilized to print dental or orthodontic appliances such as occlusal splints, nightguards, mouthguards and repositioners is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.
Device Description
Dental LT Comfort Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances, such as occlusal splints, nightguards, mouthguards and repositioners by additive manufacturing.
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K Number
K230548Device Name
Myoaligner Appliance
Manufacturer
Myohealth Technologies, LLC
Date Cleared
2024-02-02
(339 days)
Product Code
MQC, OCO
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For protection against teeth grinding, and jaw clenching; protections from injury due to bruxism or clenching; relief of bruxism related headaches, migraines and pain; short-term relief from muscle spasm due to occlusal interference; prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscles; and temporary treatment of temporal mandibular disorder (TMD) along with the relief of associated headaches and pains in adults 18 years of age or older.
Device Description
The Myoaligner appliance is a customized, removable dental device which is designed to overlay the existing dentition without the need for any alterations done to the receiving dentition. The appliance is a plural piece intra-oral removable appliance, which is designed and delivered to the patients by a licensed practitioner such as a dentist (Rx only). The dentist can prescribe a device that fits over the 4-6 front teeth, back teeth on both sides of the dental arch or all of the teeth in the dental arch both on the upper or lower jaw. The appliance is held in place by mechanical retention. The Myoaligner appliance can be worn on either the top or bottom teeth or both. It is intended for use in adults 18 years of age and older.
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K Number
K230592Device Name
LuxCreo Dental Night Guard Resin
Manufacturer
LuxCreo Inc.
Date Cleared
2024-01-18
(321 days)
Product Code
MQC, KMY
Regulation Number
N/AWhy did this record match?
Product Code :
MQC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LuxCreo Dental Night Guard Resin is a liquid light-curing resin product indicated for the creation of orthodontic and dental appliances such as mouthguards, splints, and repositioners.
Device Description
LuxCreo Dental Night Guard Resin is a liquid light-curing resin product.
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