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510(k) Data Aggregation
K Number
K030727Device Name
POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT
Manufacturer
Date Cleared
2003-06-05
(90 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
HEALEX PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For luting temporary crowns to prepared crowns.
Device Description
Not Found
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K Number
K961457Device Name
SUBLIMINATOR
Manufacturer
Date Cleared
1996-07-18
(93 days)
Product Code
Regulation Number
872.6770Why did this record match?
Applicant Name (Manufacturer) :
HEALEX PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
for the surgeless delivery of local anesthetics (and fluids) into tissues.
Device Description
The Subliminator (motorized, controlled delivery device) utilizes the identical needles in an identical way ie, they are either disposable or reusable, attached onto the Subliminator, discarded after use in Sharp's containers when they are removed, and sterilized exactly the same as described above.
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K Number
K954976Device Name
POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)
Manufacturer
Date Cleared
1996-04-25
(181 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
HEALEX PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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