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Found 6 results
510(k) Data Aggregation
K Number
K102526Device Name
BLO2X OXYGEN BLOCKER
Manufacturer
Date Cleared
2010-10-22
(50 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PASCAL CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BLO2X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. BLO2X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
Device Description
BLO2X Oxygen Blocker is a clear, glycerin-based gel containing a viscosity-inducing agent, producing a gel with similar viscosity characteristics to the predicate product.
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K Number
K090597Device Name
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
Manufacturer
Date Cleared
2009-03-16
(11 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
PASCAL CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.
Device Description
The modified varnish has the following similarities to that which previously received 510(k) concurrence:
- Has the same active ingredient at the same concentration; .
- has the same indications for use; .
- incorporate the same or similar materials; .
- has the same shelf life, and; ●
- is packaged using the same materials and processes.
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K Number
K040988Device Name
ZIRCON-F PROPHYLAXIS PASTE
Manufacturer
Date Cleared
2004-07-07
(83 days)
Product Code
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
PASCAL CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Device Description
Zircon-F Prophylaxis Paste
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K Number
K040661Device Name
RADENT PROPHY PASTE
Manufacturer
Date Cleared
2004-06-09
(89 days)
Product Code
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
PASCAL CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Device Description
Not Found
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K Number
K012889Device Name
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
Manufacturer
Date Cleared
2003-05-27
(637 days)
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
PASCAL CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Banicide® Advanced is a reusable liquid chemical sterilant/high level disinfectant intended to (1) sterilize medical instruments at an exposure time of 10 hours and an exposure temperature of 25℃ and a minimum effective concentration of 1.8% glutaraldehyde; and (2) provide high level disinfection at an exposure time of 45 minutes and an exposure temperature of 25°C and a minimum effective concentration of 1.8% glutaraldehyde. It may be re-used for a period of 30 days provided the solution remains above the MEC as confirmed by a chemical indicator test strip.
Device Description
Single container glutaraldehyde solution for sterilization and high level disinfection
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K Number
K030488Device Name
FLUORILAQ
Manufacturer
Date Cleared
2003-05-02
(77 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
PASCAL CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Int inded for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive roc t surfaces.
Device Description
Not Found
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