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Found 11 results
510(k) Data Aggregation
K Number
K974231Device Name
POSITION PENTA, POSITION PENTA QUICK
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1998-01-29
(78 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Position® Penta and Position® Penta Quick are indicated for use for impressions for temporary restorations, preliminary impressions, opposing dentitians and orthodontic models.
Device Description
Position® Penta and Position® Penta Quick are slightly modified impression materials. Position® Penta, Position® Penta Quick and Dimension® Penta H are all composed of a base paste and catalyst. Position® Penta, Position® Penta Quick and Dimension® Penta H have the same catalyst composition except for use of a pigment identified as an alternative in the Dimension® Penta 510(k). The base paste composition of the products are similar, with the exception of: (1) variations of ingredient amounts; (2) use in Position® Penta and Position® Penta Quick of a new form/chemical structure of a previously used ingredient (silyl polyethylene oxides); and (3) use of new pigments identified as alternatives in the Dimension® Penta 510(k).
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K Number
K973513Device Name
SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1997-12-22
(96 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sinfony® system is indicated for use as a light-curing composite veneer material for:
- full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments
- implant superstructures .
- adhesive bridgework .
- laminate veneers .
- o individualizing denture teeth
- individualizing long-term temporary restorations .
Device Description
light-curing composite veneer material
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K Number
K973262Device Name
KETAC-FIL APLICAP PLUS
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1997-11-17
(80 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ketac-Fil® Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.
Device Description
Ketac-Fil® Aplicap® Plus is a modified glass ionomer cement material. Modifications have been made to the following ESPE 510(k)s for glass ionomer cement material: (1) Photac-Fil® Aplicap® (K925027); and (2) Ketac-Molar® Aplicap® (K960954), to create a slightly modified product with two new pigments.
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K Number
K972892Device Name
CAVIT-LC
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1997-10-02
(58 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Temporary fillings for inlay and onlay preparations .
Temporary fillings of cavities ●
Temporary filling of implant sites ●
Relining of prefabricated temporary crowns and bridges .
Device Description
light-curing temporary filling material, tradenamed Cavit®-LC
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K Number
K963735Device Name
COJET SYSTEM
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-11-27
(71 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoJet™-System's intraoral adhesive restoration repair and adhesive cementation uses include:
- adhesive repair of defects in porcelain
- adhesive repair of defects in porcelain with exposed metal -
- adhesive repair of defects in composite -
- adhesive repair of defects in composite with exposed metal
- conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
- conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.
Device Description
4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The components are CoJet™-Sand, a silane coupling agent, a bonding material, and an Opaquer.
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K Number
K963737Device Name
HYCEM APLICAP
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-11-15
(59 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.
Device Description
compomer luting cement, tradenamed Hycem® Aplicap®
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K Number
K962428Device Name
EBS (ESPE BONDING SYSTEM)
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-09-12
(80 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
intended to bond composite materials to the tooth structure
Device Description
3-component resin tooth bonding system, tradenamed EBS® (ESPE Bonding System). The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.
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K Number
K962440Device Name
PERTAC II/PERTAC II APLITIP
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-09-11
(79 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
(1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.
Device Description
modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials
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K Number
K962442Device Name
HYTAC APLITIP/HYTAC OSB
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-09-11
(79 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.
Device Description
Hytac® Aplitip® is a compomer filling material. Hytac® OSB is a light cured bonding agent.
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K Number
K960954Device Name
KETAC-MOLAR APLICAP
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-05-16
(66 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
**ESPE GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.
Device Description
slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar Aplicap®. The reason for this modification is to provide for an improved compressive strength.
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