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Found 6 results
510(k) Data Aggregation
K Number
K162046Device Name
MINNE TIES MMF Suture System
Manufacturer
SUMMIT MEDICAL, INC.
Date Cleared
2017-04-11
(260 days)
Product Code
DYX
Regulation Number
872.4600Why did this record match?
Product Code :
DYX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MINNE TIES™ MMF Suture System is an adjustable flexible plastic band that wraps between and around a tooth to create an anchorage point for maxilla-mandibular fixation and immobilization. MINNE TIES™ MMF Suture System is suitable for:
- Pre-operative fixation
- Per-operative fixation
- Short-term (up to 3 weeks) fixation for minimally displaced fractures
- Splintage post jaw dislocation
Device Description
The MINNE TIES™ MMF Suture System contains:
- Four (4) 1.0mm sized sutures
- Seven (7) 0.7mm sized sutures
- One (1) 0.5mm Sized suture
and are used to establish maxilla-mandibular fixation (MMF) and immobilization by applying independently balanced series of sutures bilaterally between and/or around the teeth in the interdental space (i.e. triangular apical embrasure). The sutures provide a stabilizing occlusive force allowing for short term (up to 3 weeks) fixation for minimally displaced fractures for pre-operative and per-operative fixation and splintage post jaw dislocation. An Introducer is used to advance sutures between and/or around the teeth. A cheek retractor is included with the system to organize the ties during the procedure.
The MINNE TIES™ MMF Sutures are made of polypropylene, polyester and stainless steel. The cheek retractor is made of polypropylene.
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K Number
K061271Device Name
ERCH ARCH BAR, MODEL 38-690-00
Manufacturer
KLS-MARTIN L.P.
Date Cleared
2006-06-30
(56 days)
Product Code
DYX
Regulation Number
872.4600Why did this record match?
Product Code :
DYX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.
Device Description
The Erich Arch Bar is made of fully annealed electro polished stainless steel which is affixed temporarily to the teeth by an oral surgeon or dentist with ligature wire. The installed device provides temporary jaw immobilization.
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K Number
K031207Device Name
SAFETY RELEASE ARCH BAR KIT
Manufacturer
CASEY SURGICAL, LLC
Date Cleared
2003-07-15
(90 days)
Product Code
DYX
Regulation Number
872.4600Why did this record match?
Product Code :
DYX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.
Device Description
The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.
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K Number
K030605Device Name
RAPID IMF
Manufacturer
ZYGOMATICS LTD.
Date Cleared
2003-06-27
(122 days)
Product Code
DYX
Regulation Number
872.4600Why did this record match?
Product Code :
DYX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for:
- Pre-operative fixation
- Per-operative fixation
- Short-term (up to 3 weeks) fixation for minimally displaced fractures
- Splintage post jaw dislocation
Device Description
The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band).
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K Number
K990212Device Name
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
Manufacturer
DOCTOR'S RESEARCH GROUP, INC.
Date Cleared
1999-09-14
(235 days)
Product Code
DYX
Regulation Number
872.4600Why did this record match?
Product Code :
DYX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.
Device Description
DRG LockJaw™ 15 Minute Intermaxillary Fixation System
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K Number
K991004Device Name
SYNTHES QUICK LOCK IMF SYSTEM
Manufacturer
SYNTHES (USA)
Date Cleared
1999-06-23
(90 days)
Product Code
DYX, DAT
Regulation Number
872.4600Why did this record match?
Product Code :
DYX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthes Quick Lock™ IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.
Device Description
The Synthes Quick Lock ™ IMF System consists of brackets, arch bars and instrumentation which are used to facilitate temporary jaw immobilization. The Synthes Quick Lock ™ Bracket is a dental bracket that provides an attachment point for MMF wires and elastics. It incorporates a high tensile strength fiber that circumdentially attaches the bracket to the dentition. The Quick Lock ™ Arch Bar and Arch Bar Bracket provide additional support to the dental arch.
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