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Found 4 results
510(k) Data Aggregation
K Number
K990060Device Name
MACH 7
Manufacturer
KREATIV, INC.
Date Cleared
2000-06-15
(524 days)
Product Code
KOJ
Regulation Number
872.6080Why did this record match?
Applicant Name (Manufacturer) :
KREATIV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes I, III, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.
Device Description
The Mach 7 is an air abrasion pneumatic device which combines pressurized air and aluminum oxide powder to product a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill. The system is designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.
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K Number
K983227Device Name
POWER BLOCK
Manufacturer
KREATIV, INC.
Date Cleared
1998-12-11
(87 days)
Product Code
EIE, DAT
Regulation Number
872.6300Why did this record match?
Applicant Name (Manufacturer) :
KREATIV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PowerBlock is a white, light reflective, paint on dam which, when light cured, will form a semi-plastic barrier which protects gingival tissue.
Device Description
PowerBlock is a white, light reflective, paint on dam.
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K Number
K980216Device Name
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
Manufacturer
KREATIV, INC.
Date Cleared
1998-06-16
(146 days)
Product Code
KOJ
Regulation Number
872.6080Why did this record match?
Applicant Name (Manufacturer) :
KREATIV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kreativ Mach Series Air Abrasion systems are used for cavity preparation in Classes I, II, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. They are also used for restoration prophylaxis.
Device Description
The Mach 5, Mach 5 plus, Mach 6 are pneumatic devices which combine pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The units are capable of removing dental caries, old restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a high speed dental drill. The systems are designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.
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K Number
K962376Device Name
KREATIV KURING LIGHT SYSTEM
Manufacturer
KREATIV, INC.
Date Cleared
1997-03-21
(274 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
KREATIV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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