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510(k) Data Aggregation
K Number
K133527Device Name
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
Manufacturer
OSSTEM GERMANY GMBH
Date Cleared
2014-03-07
(112 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
OSSTEM GERMANY GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Suflex Putty is to be used as panasil putty material for;
- Two step putty impression technique
- One step putty impression technique
- Two step putty impression technique using a foil(plastic putty spacer) .
- One step putty impression technique for forming functional peripheries. -
Suflex Heavy is to be used a s panasil tray material for;
- One step impression technique using sinte or dual viscosities. ।
- Two step impression technique using dual viscosities ।
- Functional impressions. -
Suflex Mono is to be used as panasil monophase material for;
- Taking impression over fixed/removable restorations and implants -(transferring impression posts and bridge components)
- -Fuctional impresssions.
- Fabricating crown and bridgework or inlays. .
- Fabricating full or partical dentures. .
- Reline impressions. י
- Use in the simultaneous mixing technique as well as the putty -
- Trnasferring root posts when fabricating posts and cores indirectly. .
Suflex Light is to be used as panaasil contact material for;
- Two step putty impressiontechnique. ।
- One step putty impression technique. ।
- One step impression technique using a foil(plastic putty spacer) l
- One step impression technique(simultaneous technique)using dual viscosities. .
- -Reline impressions.
- Fabricating full or partial dentures. -
Device Description
Suflex Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Suflex Impression Material family consists of four different viscosities(putty, heavy, mono, light), available in an assortment of delivery systems: traditional 1:1 50ml, automix cartridge, 5:1 362ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.
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