PERMA LABORATORIES LLC

Address:120 Wakefield Run Blvd,Hinckley,OH,44233,US

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Device Description : A device consisting of a material such as plastic resin that is intended to be a A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

Device Class : 2

Duns Number: 111780698

Premarket Exempt : No

Product Code : EBP

Prescription Use : No

Device Count : 1

Device Description : A device consisting of a material such as plastic resin that is intended to be a A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

Device Class : 2

Duns Number: 111780698

Premarket Exempt : Yes

Product Code : EBP

Prescription Use : No

Device Count : 1

Device Description : A convenient collection of equipment and materials typically used in an emergenc A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.

Device Class : 2

Duns Number: 111780698

Premarket Exempt : Yes

Product Code : EBO

Prescription Use : No

Device Count : 1