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Found 4 results
510(k) Data Aggregation
K Number
K113568Device Name
MTA-FILLAPEX
Manufacturer
PAXMED INTERNATIONAL
Date Cleared
2012-08-21
(263 days)
Product Code
KIF, CLA
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
PAXMED INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MTA Fillapex is a root canal sealer intended for the permanent sealing of root canals and may be used in combination with root canal obturation materials.
Device Description
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin root canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA Fillapex is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation. The device is provided non-sterile.
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K Number
K022038Device Name
SPI ONETIME DENTAL IMPLANT
Manufacturer
PAXMED INTERNATIONAL
Date Cleared
2002-07-15
(21 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
PAXMED INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thommen SPI® ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Device Description
The two-stage HA-Ti Dental Implant acquired from HATI Dental AG by Thommen Medical AG has been modified to make it a one-piece one-stage transgingival implant and will be marketed as the SP1® ONETIME Dental Implant. Other components of the HA-Ti Dental Implant System have not been modified and are suitable for use with the modified implant, and will be sold under the SP10 Dental Implant System name.
The Thommen SP1® ONETIME Dental Implant is a one-stage root form endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transqingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in three lengths (8 mm, 11 mm, 14 mm, not including the 2.9 mm transgingiyal portion), with two diameters (4.2 mm, 5.0 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance,
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K Number
K010467Device Name
UNIVERSAL DENTAL COPING (UDC)
Manufacturer
PAXMED INTERNATIONAL
Date Cleared
2001-09-28
(224 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
PAXMED INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011223Device Name
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
Manufacturer
PAXMED INTERNATIONAL
Date Cleared
2001-09-20
(153 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
PAXMED INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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