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510(k) Data Aggregation
K Number
K012882Device Name
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
Manufacturer
THERMOELASTIC TECHNOLOGIES, INC.
Date Cleared
2001-11-14
(78 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
THERMOELASTIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.
Device Description
Not Found
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K Number
K994357Device Name
BITEM LOCK, MODELS SW006, SW012
Manufacturer
THERMOELASTIC TECHNOLOGIES, INC.
Date Cleared
2000-03-14
(78 days)
Product Code
EJF
Regulation Number
872.5410Why did this record match?
Applicant Name (Manufacturer) :
THERMOELASTIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.
Device Description
The BITEM LOCK product is a thermo-adjustable alignment bracket with the same use as the predicate device. The only difference is the predicate device is Made from metal and this device is a thermo-adjustable material. The base materials for the BITEM LOCK include a methacrylate liquid, a phthalate plasticizer, an EGDMA cross linker and polymer powder. They are ready made for clinical application.
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