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510(k) Data Aggregation

    K Number
    K203596
    Device Name
    Panthera Occlusal Appliance
    Manufacturer
    Panthera Dental Inc.
    Date Cleared
    2021-04-20

    (132 days)

    Product Code
    MQC, OCO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Panthera Dental Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panthera Occlusal Appliance is indicated for protections from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.
    Device Description
    The Panthera Occlusal Appliance is a removable intraoral device used for protecting teeth and restorations against the forces of bruxism. It consists of patient-specific splint that fit over the upper or lower teeth. This device functions as a protective barrier for teeth and restorations by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (like grinding and clenching) and alleviating temporomandibular joint, jaw, and muscle and tension headache pains. There are various occlusal designs for this application, all with varying degrees of function and suitability depending on the patient's needs. The Panthera Occlusal Appliance is customized for each patient based on the clinician's prescription, and is to be worn every day during hours of sleep.
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    K Number
    K192108
    Device Name
    Panthera Dental Milled Bars
    Manufacturer
    Panthera Dental Inc.
    Date Cleared
    2020-04-08

    (247 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Panthera Dental Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained. The Panthera Dental Milled Bars are indicated for compatibility with: - · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5 - NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5 - NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0 - NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0 - Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0
    Device Description
    The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications. The Type I bars are specific for removable overdenture and include: - . Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar. The Type II bars are specific for fixed prostheses and include: - Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar. The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory. The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
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    K Number
    K183580
    Device Name
    Panthera Dental Milled Bars
    Manufacturer
    Panthera Dental Inc.
    Date Cleared
    2019-06-20

    (181 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Panthera Dental Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained. The Panthera Dental Milled Bars are indicated for compatibility with: - Standard/Standard Plus RN Ø 4.1/4.8 (platform Ø 4.8) - Standard/ Standard Plus/Tapered Effect WN Ø 4.8 (platform Ø 6.5) - Tapered Effect RN Ø 4.1 (platform Ø 4.8) - Bone Level/ Bone Level Tapered NC Ø 3.3 (platform Ø 3.3) - Bone Level/ Bone Level Tapered RC Ø 4.1, 4.8 (platforms Ø 4.1 and 4.8)
    Device Description
    The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications. The Type I bars are specific for removable overdenture and include: - Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar. The Type II bars are specific for fixed prostheses and include: - Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual. Pin Lingual Bar and Pin Wrap-Around Bar. The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory. The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
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    K Number
    K171576
    Device Name
    The Panthera Anti-Snoring X3 Device
    Manufacturer
    Panthera Dental Inc.
    Date Cleared
    2018-02-22

    (268 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Panthera Dental Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharvngeal space, improving their ability to exchange air during sleep. The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The maximum protrusion of the device is 5 mm in 1 mm increments.
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    K Number
    K173466
    Device Name
    Panthera Dental Milled Bars
    Manufacturer
    Panthera Dental Inc.
    Date Cleared
    2018-01-26

    (79 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Panthera Dental Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained. The Panthera Dental Milled Bars are indicated for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5.
    Device Description
    The Panthera Dental Milled Bar is a metallic dental restorative device which is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications. The Type I bars are specific for removable overdenture and include: - Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar. The Type II bars are specific for fixed prostheses and include: - Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar. The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression: the model cast is prepared beforehand by the dental professional using standard dental techniques. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing software system (CAD/CAM). The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory. The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.
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    K Number
    K143244
    Device Name
    The Panthera Anti-Snoring Device
    Manufacturer
    Panthera Dental Inc.
    Date Cleared
    2014-12-15

    (33 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Panthera Dental Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panthera Anti-Snoring Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the dentist. The maximum protrusion of the device is 15 mm in 1 mm increments.
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