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Found 17 results
510(k) Data Aggregation
K Number
K212283Device Name
BioRoot Flow 0.5g, BioRoot Flow 2g
Manufacturer
Septodont
Date Cleared
2021-09-16
(57 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Septodont
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. Permanent root canal filling in combination with gutta-percha points following a retreatment procedure.
Device Description
BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is hydrophilic mineral root canal sealer presented as a ready-to-use paste in a syringe. BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is based on a tricalcium silicate reaction with in situ water to seal the root canal. The sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and an adequate radiopacity. It is an implantable medical device intended to be used in dentistry. It is part of endodontic cements used as permanent root canal sealer. BioRoot™ Flow 0.5g. BioRoot™ Flow 2g is used in combination with gutta-percha points to fill the root canal.
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K Number
K211799Device Name
Biodentine XP 500, Biodentine XP 200
Manufacturer
Septodont
Date Cleared
2021-08-10
(61 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Septodont
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In the crown:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Permanent dentine restoration under composites or Inlay/Onlay
- Temporary dentine-enamel restoration;
- Restoration of deep and/or large coronal carious lesions (sandwich technique);
- Restoration of cervical or radicular lesions.
On the pulp:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Pulp capping (direct and indirect).
- Pulpotomy for diagnosed symptoms of reversible pulpitis where bleeding is controlled within 5 minutes.
In the root:
For permanent teeth (immature or mature):
- Repair of root perforations;
- Repair of furcation perforations;
- Repair of perforating internal resorptions;
- Repair of external resorption;
- Root-end filling in endodontic surgery (retrograde filling).
For immature permanent teeth
- Apexification;
Device Description
Biodentine™ XP 500, Biodentine™ XP 200 is a bioactive dentin substitute. The product is prepared from a mixture of a Biodentine™ XP 500, Biodentine™ XP 200 powder and a liquid. The product is presented in all-in-one cartridge containing thepowder phase and the liquid phase, ready to be mixed.
The medical device is presented in two presentations, the Biodentine™ XP 500 for the extraction of 500mg of finished product and the Biodentine™ XP 200 for the extraction of 200mg of finished product. The subject device is to be used with 2 accessories, the Biodentine™ Mixer and the Biodentine™ Gun.
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K Number
K172839Device Name
ENDOSOLV
Manufacturer
Septodont
Date Cleared
2018-02-13
(147 days)
Product Code
KIF, KJJ
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Septodont
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Root canal sealers solvent when canal retreatment is required.
Device Description
ENDOSOLV (new device, K172839/S001) is a solvent used for eugenate-type or phenolic resin-based endodontic cements in the context of endodontic retreatment. This solvent is able to soften conventional zinc oxide eugenol cements and phenolic resin type sealers in the context of endodontic retreatment. It is indicated for use as a root canal sealer solvent when canal retreatment is required. ENDOSOLV (new device, K172839/S001) composition consists of ethyl acetate, amyl acetate and thymol. Ethyl acetate and amyl acetate are the two main components of the formulation that are effective in dissolving zinc oxide-eugenol-based and resin based filling material.
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K Number
K140132Device Name
BIODENTINE
Manufacturer
SEPTODONT
Date Cleared
2014-06-27
(161 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
SEPTODONT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biodentine™ is indicated to be used: In the crown: - Permanent dentine restoration under composites or Inlay/Onlay - Temporary dentine-enamel restoration. - Restoration of deep and/or large coronal carious lesions (sandwich technique). - Restoration of cervical radicular lesions. - Pulp capping. - Pulpotomy. In the root: - Repair of root perforations. - Repair of furcation perforations. - Repair of perforating internal resorptions. - Repair of external resorption - Apexification. - Root-end filling in endodontic surgery (retrograde filling).
Device Description
Not Found
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K Number
K110058Device Name
BPA-FREE PIT AND FISSURE SEALANT
Manufacturer
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
Date Cleared
2011-03-31
(80 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
DBA SEPTODONT AND CONFI-DENTAL PRODUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.
Device Description
Not Found
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K Number
K101540Device Name
GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
Manufacturer
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
Date Cleared
2010-10-29
(148 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DBA SEPTODONT AND CONFI-DENTAL PRODUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.
N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.
Device Description
Not Found
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K Number
K093711Device Name
RACEGEL
Manufacturer
SEPTODONT
Date Cleared
2010-02-17
(78 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SEPTODONT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Racegel™ is a gel containing aluminium chloride which is intended for sulcus retraction prior to impression taking; control of bleeding and gingival oozing, particularly in restorative dentistry; and, if using a gingival retraction cord, the gel facilitates the insertion of the cord into the sulcus.
Device Description
Racegel™ is a gel containing aluminium chloride.
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K Number
K092251Device Name
BIODENTINE
Manufacturer
SEPTODONT
Date Cleared
2009-10-30
(94 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
SEPTODONT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When used in the crown:
- Temporary enamel restorative material.
- Permanent dentine restorative material.
- Restoration of deep and/or large coronal carious lesions (sandwich technique).
- Restoration of deep cervical and/or radicular lesions.
- Pulp capping.
- Pulpotomy.
When used in the root:
- Repair of root perforations.
- Repair of furcation perforations.
- Repair of perforating internal resorptions.
- Repair of external resorption
- Apexification.
- Root-end filling in endodontic surgery (retrograde filling).
Biodentine is not to be used for permanent obturation or sealing of the root canal
Device Description
Not Found
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K Number
K063634Device Name
RTR SYRINGE
Manufacturer
SEPTODONT
Date Cleared
2007-05-11
(156 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
SEPTODONT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RTR® SYRINGE is designed for the replacement of bone losses, after being impregnated with the patient's blood or with a physiological solution for craniofacial indications in the dental practice such as filling tooth sockets.
Device Description
Not Found
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K Number
K051010Device Name
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
Manufacturer
SEPTODONT
Date Cleared
2005-05-02
(11 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
SEPTODONT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
Device Description
Not Found
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