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510(k) Data Aggregation
K Number
K170423Device Name
DentureID Microchip
Manufacturer
CMP Industries LLC
Date Cleared
2017-10-25
(254 days)
Product Code
PYQ, LWH, NRV, OUG
Regulation Number
880.6300Why did this record match?
Applicant Name (Manufacturer) :
CMP Industries LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances.
Device Description
DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DentureID.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient.
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K Number
K170375Device Name
Nobilplast Denture Resin
Manufacturer
CMP Industries LLC
Date Cleared
2017-10-02
(237 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
CMP Industries LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night quards.
Device Description
Nobilplast Denture Resin is a polyamide (nylon) resin available in pink and white colors. The resin granules are packaged in injectable aluminum cartridges or sold in a bulk container where users can fill empty aluminum cartridges that are sold separately.
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K Number
K072851Device Name
POLYSTAR 79 DENTURE BASE RESIN
Manufacturer
CMP INDUSTRIES LLC.
Date Cleared
2008-02-20
(139 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
CMP INDUSTRIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K072402Device Name
FLEX-STAR V
Manufacturer
CMP INDUSTRIES LLC.
Date Cleared
2007-10-19
(53 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
CMP INDUSTRIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CMP's Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards. It is to be used only by professional dental practitioners who make or repair dentures for patients
Device Description
Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards.
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K Number
K033020Device Name
IMPAK ACRYLIC REPAIR RESIN LIQUID
Manufacturer
CMP INDUSTRIES LLC.
Date Cleared
2003-12-19
(84 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
CMP INDUSTRIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CMP' IMPAK denture relining, repairing/rebasing liquid resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base.
Device Description
Not Found
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