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510(k) Data Aggregation
K Number
K173124Device Name
PEEK Biosolution
Manufacturer
Merz Dental GmbH
Date Cleared
2017-12-18
(80 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Merz Dental GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PEEK Biosolution is intended to be used for the fabrication of permanent dental restorations using CAD/CAM techniques. These are:
- Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector cross-section)
- Crown copings and bridge substructures for composite veneering (max. 2 pontics and min.13 mm² connector cross-section))
- Telescopic primary and secondary crowns and frameworks
- Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide.
Device Description
PEEK Biosolution is a solid disc composed of polyether ether ketone (PEEK) and is indicated for the fabrication of permanent dental restorations using CAD/CAM techniques and equipment.
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K Number
K140758Device Name
M-PM-DISC (PINK)
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2014-09-15
(173 days)
Product Code
EBI, EBG
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device for fabrication of dental bases for removable dentures.
Device Description
The Merz Dental GmbH M-PM-Disc (Pink) is a disc composed of solid polymethylmethacrylate (PMMA) in sizes ranging from 90 x15 mm to 114.8 x 25 mm.
The PMMA is a highly cross-linked material manufactured by Merz Dental GmbH under a proprietary process and branded as OMP-N. MP-M-Disc (Pink) is composed of > 95 % PMMA with less than 2% MMA residual. Additional components are coloring agents that include: titanium dioxide, iron oxide yellow, iron oxide black, iron oxide red, azocondensation pigment red, and rayon fibers for veined shades.
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K Number
K134015Device Name
M-PM-DISC
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2014-04-11
(105 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguard and nightguards.
Device Description
The Merz Dental MP-M-Disc (Clear) is a solid disc composed of a highly cross-linked homogenous combination of polymethylmethacrylate (PMMA) copolymers known as an Interpenetrated Polymer Network (IPN). This is the same material used in Merz Dental artegral Denture Teeth (K030588) and the Merz Dental M-PM-Disc (Tooth Colored) (K071548). The difference is that the MPM-Disc (Clear) PMMA does not have added pigments. The M-PM-Disc (Clear) PMMA contains polymethylmethacrylate cross-linked polymer based on methacrylic acid esters, residual peroxide and residual monomer up to a maximum of 1%. It is offered in sizes from 90 x15 mm to 114.8 x 25 mm. Bite splints are prepared from the disc using a milling technique.
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K Number
K130076Device Name
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2013-08-22
(220 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for:
- Relining a denture surface that contacts tissue ●
- Repairing a fractured denture, or
- Forming a new denture base
Device Description
Merz Dental Denture Base Resins with Prosthetic Color System are composed of the following products:
• Promolux: A heat processed PMMA denture base resin
• Promolux Hi: A heat-processed PMMA denture base resin formulated for greater strength
· Weropress: A two part cold curing PMMA denture base resin
: PremEco PCS: A two part cold curing PMMA denture base resin with individual tints for aesthetic coloration of gingival portion of a denture base
These products are intended for the preparation of denture bases. They are composed of PMMA and cured by standard heat or cold setting methods. The Prosthetic Color System is a three part system composed of the following: (1) PMMA polymer with various tints in a powder form, (2) MMA liquid for mixing with the powder, and (3) a cold-casting resin (PMMA and MMA) for final preparation of the denture base. The hot and cold curing denture materials contain standard dental colorants and catalyst systems. One of the hot cured dental base materials, Promolux Hi, is formulated to increase impact resistance.
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K Number
K120404Device Name
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2012-05-21
(102 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artegral HD are posterior preformed plastic denture teeth for use in:
- supra construction for combined, fixed removable dental prostheses .
- hybrid construction for implant-supported dental prostheses .
- cover denture .
- total prostheses .
- model cast prostheses ●
- . partial dentures
Device Description
artegral HD are preformed posterior plastic teeth made from an Interpenetrated Network (IPN) of polymethylmethacrylate (PMMA) with two finer Networks. The tooth neck is made from Organic Modified Polymer Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.
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K Number
K080556Device Name
ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2008-05-02
(64 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.
Device Description
A rectangular solid block of PMMA with post attachment for use in a CAD-controlled milling device for production of long-term temporary crowns and bridge abutments.
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K Number
K071548Device Name
WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2007-08-21
(76 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a milling blank in the fabrication of provisional crowns and bridges.
Device Description
Discs of PMMA in two sizes and three shades for milling into provisional crowns and bridges
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K Number
K061809Device Name
ARTEGRAL IMCROWN
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2006-09-13
(78 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
artegral ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.
Device Description
Various shapes and sizes of preformed anterior crowns composed of IPN-PMMA with an attachment device for use in the CEREC 3D and inLab Systems.
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K Number
K030588Device Name
ARTEGRAL AND POLYSTAR SELECTION
Manufacturer
MERZ DENTAL GMBH
Date Cleared
2003-05-07
(71 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
MERZ DENTAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artegral, and Polystar® Selection are intended for use as teeth in dentures.
Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN) intended for use as teeth in dentures.
Device Description
Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN).
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