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Found 4 results
510(k) Data Aggregation
K Number
K132102Device Name
BECE CAD ZIRKON HT+
Manufacturer
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
Date Cleared
2013-11-12
(127 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.
- Fully anatomical crowns and bridges -
- Partial-veneered and fully veneered crowns and bridges -
- Dentine core crowns and bridges -
- Maryland bridges -
- Telescopic crowns (primary part) -
Device Description
BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.
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K Number
K123929Device Name
BEGOPAL+
Manufacturer
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
Date Cleared
2013-03-14
(84 days)
Product Code
EJH
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
**BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.
Device Description
BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.
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K Number
K090434Device Name
BECE PRESS
Manufacturer
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
Date Cleared
2009-07-06
(137 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BeCe PRESS Ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. The pressable ceramics can be pressed to frames made of precious or non-precious alloys with a CTE of 14.6 x 10-6 K-1 (20ºC to 500ºC) after application of opaquer. Applications range from single tooth crowns to various size bridges.
Device Description
BeCe PRESS is a dental ceramic system for veneering metal copings and frameworks using a press on alloy technique. The pressing ingots are composed of a two-phase leucite reinforced silicate ceramic. The restoration is processed according to the lost wax technique. The opaqued mteal framework is first waxed-up in the desired shape an function and invested. After burning out of the wax the heated, ductile BeCe PRESS ceramic is pressed into the previously created hollow space by a special ceramic press-furnace. After devesting, the restoration can be individually characterized by shade/stains and glaze materials with accompanying liquids
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K Number
K983081Device Name
BEGOPAL 300
Manufacturer
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
Date Cleared
1998-10-28
(56 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
**BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal is a declaration by the manufacturer that the regulation requirements are met.
Device Description
BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy.
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