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Found 10 results
510(k) Data Aggregation
K Number
K211721Device Name
PS System
Manufacturer
Inter-Med, INC.
Date Cleared
2021-12-02
(181 days)
Product Code
NYL
Regulation Number
872.4200Why did this record match?
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Matched: '872.6300'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
Device Description
The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
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K Number
K182118Device Name
armor LC
Manufacturer
Mavrik Dental Systems Ltd
Date Cleared
2019-05-03
(270 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
Device Description
armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.
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K Number
K151945Device Name
Triumph Resin Dam
Manufacturer
DENALI CORPORATION
Date Cleared
2016-02-18
(219 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.
Device Description
Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.
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K Number
K071615Device Name
FIXAFLOSS
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2007-09-21
(100 days)
Product Code
EEF
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams.
The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.
Device Description
The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.
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K Number
K050318Device Name
BARI-KAD PACKING DEVICE
Manufacturer
BIOENVELOP AGRO, INC.
Date Cleared
2005-03-04
(23 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bari-Kad™ is a device intended to protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening.
Device Description
Bari-Kad™ Packing Device
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K Number
K043301Device Name
GC TION GINGIVAL PROTECTOR
Manufacturer
GC AMERICA, INC.
Date Cleared
2005-01-25
(56 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.
Device Description
Not Found
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K Number
K040797Device Name
BRITESMILE MASKING CREAM
Manufacturer
BRITESMILE, INC.
Date Cleared
2004-04-02
(4 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.
Device Description
The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
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K Number
K022522Device Name
PULPDENT PUTTY DAM
Manufacturer
PULPDENT CORPORATION
Date Cleared
2002-09-26
(58 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
Device Description
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
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K Number
K021524Device Name
LIGHT CURE DENTAL DAM
Manufacturer
PRIME DENTAL MANUFACTURING, INC.
Date Cleared
2002-07-19
(70 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prime-Dent Light Cure Soft Dental Dam is for soft tissue isolation and molsture prevention/barrier.
Device Description
Not Found
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K Number
K021613Device Name
NIVEOUS LIQUID DAM
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2002-06-20
(35 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.
Device Description
Niveous Liquid Dam is a light-cured resin used for soft tissue isolation/protection during teeth whitening procedures. The material is dispensed from a syringe into the gingival crest just shy of the tooth structure. The resin is light-cured (polymerized) on the soft tissue by exposure for 20 seconds per section of material.
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