Search Results
Found 13 results
510(k) Data Aggregation
K Number
K131753Device Name
MERIDIAN
Manufacturer
AB ARDENT
Date Cleared
2013-11-14
(153 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.
Device Description
Meridian is a light curing universal dental composite material of the latest nanohybrid type having an optimized chemical composition.
Ask a Question
K Number
K040465Device Name
LATIT FLOW
Manufacturer
AB ARDENT
Date Cleared
2004-07-20
(148 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I. Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Luting of porcelain and composite veneers As first layer of Class I or II restorations
Contra indications:
The placement of LATIT FLOW is contraindicated
If a dry working field cannot be established or if the stipulated technique cannot be applied.
If the patient is known to be allergic to the components of LATIT FLOW.
Device Description
Not Found
Ask a Question
K Number
K022971Device Name
MICROHYBRID 11
Manufacturer
AB ARDENT
Date Cleared
2002-11-25
(80 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV
Class V restorations, cervical caries, root erosion, wedge shaped defects.
Posterior restorations, Class I, II.
Splinting of mobile teeth.
Preventive restorations in molars and premolars.
Repair of composite and ceramic veneers.
Inlays/onlays with extra-oral post tempering
Device Description
Not Found
Ask a Question
K Number
K022972Device Name
MICROFILL 13
Manufacturer
AB ARDENT
Date Cleared
2002-11-22
(77 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MICROFILL 13 is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth
Device Description
Not Found
Ask a Question
K Number
K022973Device Name
ADHESIVE 14
Manufacturer
AB ARDENT
Date Cleared
2002-11-22
(77 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure.
Device Description
Not Found
Ask a Question
K Number
K022974Device Name
MICROHYBRID 12
Manufacturer
AB ARDENT
Date Cleared
2002-11-22
(77 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MICRCHYBRID 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries:
IDirect, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV
Class V restorations, cervical caries, root erosion, wedge shaped defects.
Posterior restorations, Class I, II.
Splinting of mobile teeth.
Preventive restorations in molars and premolars.
Repair of composite and ceramic veneers.
Inlavs/onlays with extra-oral post tempering
Device Description
Not Found
Ask a Question
K Number
K022975Device Name
ETCHING 15
Manufacturer
AB ARDENT
Date Cleared
2002-11-22
(77 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
E.TCHING 15 is used in the enamel or total etch techniques for Composite restorations Adhesive cementation of inlays (composite and ceramic)crowns, bridges, eneers, adhesive bridges and root posts. Splints Bonding of orthodontic attachments Fissure sealings
Device Description
Not Found
Ask a Question
K Number
K020452Device Name
HIGH SILVER CONVENTIONAL
Manufacturer
AB ARDENT
Date Cleared
2002-05-07
(85 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I
Two surface cavities such as MO, DO, FO, LO
Three surface cavities such as MOD, FOD.
Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Device Description
HIGH SILVER CONVENTIONAL
Ask a Question
K Number
K011801Device Name
FUTURA TOPCAP NON GAMMA-2
Manufacturer
AB ARDENT
Date Cleared
2001-08-16
(69 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I
Two surface cavities such as MO, DO, FO, LO
Three surface cavities such as MOD, FOD.
Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Labels will bear this caution.
Device Description
Not Found
Ask a Question
K Number
K991974Device Name
FUTURA GLASS IONOMER SILVER REINFORCED
Manufacturer
AB ARDENT
Date Cleared
1999-09-17
(98 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
AB ARDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries:
- Class I and II cavities in deciduous teeth.
- Repair of amalgam restored teeth (fractured restoration or tooth).
- Class I and II cavities in selected permanent teeth.
- Lining under amalgam or posterior composite restorations.
- Cavities where radiopacity is a prime requirement.
- Core build up material under crowns.
- On root surface for locating overdentures.
- Long term temporary replacement of cusps
- Repairs to crown margins.
Device Description
Not Found
Ask a Question
Page 1 of 2