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Found 9 results
510(k) Data Aggregation
K Number
K162662Device Name
GingiDent Gingival Retraction Paste
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2017-10-20
(389 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.
Device Description
GingiDent gingival retraction paste is an astringent formulated to provide gingival retraction and hemostasis. GingiDent gingival retraction paste contains Aluminum Chloride and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. This product is a blue-green paste developed exclusively for transient surgically invasive use in the oral cavity. The paste contains Aluminum Chloride in a water-based clay inert carrier.
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K Number
K160577Device Name
PacEndo Chlorhexidine
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2016-07-25
(146 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.
Device Description
PacEndo™ Chlorhexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
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K Number
K151123Device Name
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Manufacturer
Pac-Dent International, Inc.
Date Cleared
2016-03-03
(310 days)
Product Code
PEM
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
Pac-Dent International, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
Device Description
Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
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K Number
K153528Device Name
PacEndo EDTA
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2016-02-01
(54 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Device Description
PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove the smear layer produced from root canal instrumentation.
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K Number
K151852Device Name
PacEndo Sodium Hyprochlorite
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2015-11-10
(126 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.
Device Description
PacEndo™ Sodium Hypochlorite is a Sodium Hypochlorite solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
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K Number
K151150Device Name
Elements
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2015-07-28
(89 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
Device Description
Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.
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K Number
K141717Device Name
PACSEAL PIT & FISSURE SEALANT
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2015-03-09
(257 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PacSeal™ Pit & Fissure Sealant is intended for use as:
- Seal the pits and fissures in teeth
Device Description
PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth.
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K Number
K141422Device Name
PROFLUORO FLUORIDE VARNISH
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2014-09-30
(123 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProFluoro™ Fluoride Varnish is intended for use as:
- Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film
Device Description
ProFluoro™ Fluoride Varnish is a resin-based 5% sodium fluoride varnish applied to tooth surfaces with an applicator brush. Moisture from saliva cures the varnish and leaves a film on tooth to treat tooth hypersensitivity.
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K Number
K130672Device Name
OPTIFLOW II FLOWABLE COMPOSITE, LC
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2013-08-13
(154 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PAC-DENT INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OptiFlow II Flowable Composite, LC is intended for use as:
- Repair of minimally invasive cavity (including non-stress bearing areas)
- Pit and fissure sealant
- Class III-V restorations
- Repair of porcelain restorations
- Repair of ceramic/composite veneers
Device Description
OptiFlow II Flowable Composite, LC is a light cure resin-based flowable restorative dental composites. The restorative is packaged in capsules and syringes. The fillers are a combination of radiopaque inorganic fillers and advanced nano-silicas with an average particle size of 0.7 microns to produce a loading approximately 57% by weight (40% by volume). All shades have a radiopacity of 200%.
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