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510(k) Data Aggregation
K Number
K970134Device Name
THERMAPREP PLUS OVEN
Manufacturer
TULSA DENTAL PRODUCTS, LTD.
Date Cleared
1997-03-21
(65 days)
Product Code
EKM
Regulation Number
872.3850Why did this record match?
Applicant Name (Manufacturer) :
TULSA DENTAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The THERMAPREP® PLUS OVEN is specially developed for heating ThermaFil® endodontic obturators. Do not use the oven for any other purpose.
Device Description
The THERMAPREP® PLUS OVEN is a heating unit for obturators. The system allows for individual heating of ThermaFil® gutta percha obturators. Microwave technology is used to produce uniform predictable heating results.
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K Number
K964174Device Name
MINERAL TRIOXIDE AGGREGATE (MTA)
Manufacturer
TULSA DENTAL PRODUCTS, LTD.
Date Cleared
1997-02-10
(115 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
TULSA DENTAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated clinical applications include use as repair of pulpal exposures.
Device Description
Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure.
Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.
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K Number
K954790Device Name
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
Manufacturer
TULSA DENTAL PRODUCTS, LTD.
Date Cleared
1996-01-16
(89 days)
Product Code
DZA
Regulation Number
872.4130Why did this record match?
Applicant Name (Manufacturer) :
TULSA DENTAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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