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Found 9 results
510(k) Data Aggregation
K Number
K123276Device Name
MM-SEAL
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
2014-03-10
(507 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MM-SEAL is a root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.
MM-SEAL is intended for use by qualified healthcare personnel trained in its use.
Device Description
The MM-SEAL is a biocompatible root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.
The device consists of two component (dual syringe) which are mixed before the use in the dental canal, onto a mixing plate with a spatula for 15-20 seconds or until the mixture become creamy and homogeneous.
Application: Thoroughly dry canals walls and apply MM-SEAL, avoiding the formation of air bubbles. Do not exceed the apical limit. Dip the tips of dry, disinfected Gutta-percha points in MM-SEAL. Insert one or more points in the root canal and condense the Gutta-percha. MM-SEAL can be used with thermoplasticized gutta-percha or gutta-percha coated obturator techniques.
MM-SEAL should not be used expiry date.
MM-SEAL is intended for use by qualified healthcare personnel trained in it use.
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K Number
K103123Device Name
APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
2011-03-10
(140 days)
Product Code
LQY, LOY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APEX POINTER+ is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
Device Description
The APEX POINTER+ is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.
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K Number
K081268Device Name
SONIC AIR MM1500 + (MID), MODEL 50400014
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
2009-08-10
(462 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endodontics
canal preparation -
canal cleaning
Device Description
Not Found
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K Number
K042171Device Name
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
2004-11-10
(91 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
Device Description
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
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K Number
K971350Device Name
SERIES XE, SERIES SE, SERIES TE
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
1997-06-04
(55 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These contra-angles are intended.for use. on dental motors equipped with a coupling according to ISO Standard 3964.
The speed of the motors may not exceed 40 000 RPM.
These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as : determined in ISO Standard 1797.
They allow to carry out all low speed dental works
Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.
Device Description
Not Found
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K Number
K961275Device Name
SIRIUS 10, 10L, 40, 40L
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
1997-01-17
(289 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961235Device Name
SIRIUS 180, 180L, 230, 230L
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
1997-01-08
(285 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961494Device Name
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
1996-06-26
(69 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961076Device Name
MM 324
Manufacturer
MICRO-MEGA SOCIETE ANONYME
Date Cleared
1996-04-26
(39 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MICRO-MEGA SOCIETE ANONYME
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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