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510(k) Data Aggregation
K Number
K140976Device Name
ENADEN FLOW
Manufacturer
Date Cleared
2014-07-10
(85 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
KM CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Enaden Flow is intended for use in :
1) Restoration of class I~V cavities
2) Blocking out of undercuts
3) Sealing hypersensitive areas
Device Description
Enaden Flow is a polymer-based restorative material. Enaden Flow is visible light-cured, radiopaque flowable composite and it is easy to handle, ready to be applied to restorations directly. The Enaden Flowl is available in 5 shades: A1, A2, A3, A3.5, and B2 (according to VITAPAN® classic shade guide). The device is used for the restorations of both anterior and posterior teeth. The device is contained in a plastic syringe and the system includes a plunger, disposable needle, protective cap, and a holder for direction control of the needle.
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K Number
K133716Device Name
TRC-PASTE
Manufacturer
Date Cleared
2014-04-09
(125 days)
Product Code
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
KM CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or following pulpectomy, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutta- percha.
Device Description
TRC-Paste is an immediately available pre-mixed root canal filling material based on Calcium hydroxide and Polypropylene Glycol 2000. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or infected root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.
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K Number
K132123Device Name
TRC-PEX, RADIC-SEALER
Manufacturer
Date Cleared
2014-03-20
(253 days)
Product Code
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
KM CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TRC-Pex: The TRC-Pex is a temporary root canal sealer for use in the treatment of root canals, following a pulpectomy or for apexegenesis or apexification.
Radic-Sealer: The Radic-Sealer is a root canal sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). The Radic-Sealer is intended for use by qualified healthcare personnel trained in its use.
Device Description
TRC-Pex: TRC-Pex is an immediately available pre-mixed root canal filling material based on Calcium Hydroxide and lodoform. This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or root canal therapies, it can be used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.
Radic-Sealer: Radic-Sealer is a root canal sealing & filling material based on epoxy-amine resin. Radic-Sealer is contained in a dual syringe which makes it easy to mix and inject. It makes permanent obturation of root canals using adhesion properties between root canal walls and the root canal filling materials. The base and catalyst are contained separately in the chambers of two separate plastic syringes. The product consists of a mixing tip with a mixing joint, a protective cap, a mixing pad, and a plunger.
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