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Found 24 results
510(k) Data Aggregation
K Number
K100908Device Name
UNICEM HM
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2010-06-22
(82 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementation of post and screws; Final cementation of ceramic, composite or metal restorations on implant abutments; Cementation of abutments made of Lava™ zirconium oxide ceramic.
Device Description
Unicem HM in the Clicker™ dispenser is a dual-curing, self-adhesive resin cement for hand mixing. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70% by weight; the grain size (D 90%) is about 12.5 um. The mixing ratio; based on volume, is 1 part base paste : 1 part catalyst. The cement is available in various shades.
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K Number
K100756Device Name
MALTA
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2010-06-02
(77 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementing of posts and screws; Final cementation of all-ceramic, composite, or metal restorations on implant abutments.
Device Description
Malta is a dual-curing, self-adhesive resin cement available in an automix syringe. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70 % by weight; the grain size (D 90 %) is about 12.5 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. The two pastes are mixed by a static single use mixer attached to the syringe. Malta is available in various shades.
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K Number
K094007Device Name
UNICEM
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2010-04-08
(101 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementation of post and screws Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic
Device Description
Unicem Aplicap/Maxicap cements are dual-curing, self-adhesive resin cements available in two single dose delivery systems in capsules (K020256). They are used for the permanent cementation of indirect restorations made of ceramic, composite, or metal, and for posts and screws. Bonding and conditioning of the prepared tooth structure are not necessary with Unicem Aplicap™ and Maxicap™M. Unicem Aplicap™ and Unicem Maxicap™ release fluoride ions, and are available in various shades. Unicem Aplicap™ and Unicem Maxicap™ contain bifunctional (meth)acrylate.
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K Number
K093721Device Name
COSP2
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2010-02-19
(79 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All indications for displacement of the marginal gingiva and to provide for a dry sulcus when the periodontium is healthy.
Device Description
CoSP2, manufactured by 3M ESPE, is a retraction paste for the displacement of marginal gingiva and to provide for a dry sulcus. Any suitable, commonly available dispensers, e.g., the Capsule Applicator, manufactured for 3M ESPE, can be used for application of the retraction paste. The paste is applied directly from the retraction capsule into the sulcus. A CoSP2 retraction capsule may not be used on more than one patient.
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K Number
K091826Device Name
ELEGANT
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2009-09-25
(98 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine.
Device Description
Elegant is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Elegant is used for production of glass ceramic veneers for 3M ESPE Lava™ Frame Zirconia frameworks.
Elegant consists of 4 glass ceramic blocks (E1 - E4), from which the veneer is milled. Each ceramic block is available in the two sizes S and M. The veneer is then fused to the Zirconia framework via color-coordinated fusion porcelain (D1 - D10). For smaller adjustments to the restoration, corrective porcelains (CR1 - CR4) can be used. For the tooth colors A4, B4, C3, C4, and D4, the basic shades ("Shade" A - D) must be used. The individual stains S1 (White), S2 (Lemon Yellow), S3 (Orange), S4 (Violet), S5 (Blue), S6 (Dark Brown), and glaze are used for individualization. For the mixing of the fusion porcelain powder and the corrective porcelain, modelling liquid is available; also, for stains and glaze, stain/glaze liquid is available.
For the production of an Elegant restoration, the Lava™ Frame Zirconia framework and the corresponding Elegant veneer are virtually designed on the screen with the Lava™ Design Software. The milling for both parts takes place in the accordingly released Lava™ milling machine with special milling cutters. Subsequently the Lava™ Frame Zirconia framework is shaped and then sintered in the Lava™ sintering furnace. All of the above-mentioned Lava products are manufactured by or for 3M ESPE.
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K Number
K090718Device Name
BELLUS SHADING KIT
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2009-09-21
(187 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".
Device Description
Bellus Shading Kit contains stain pastes, a glazing paste, and a liquid which can be used to thin the pastes. The pastes serve solely for the color staining and glazing of the surfaces of restorations made from "Jolly" glass ceramic blocks, manufactured for 3M ESPE.
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K Number
K080514Device Name
PECD-01 AND PECD QUICK-01
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2008-03-26
(30 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Device Description
PECD-01 and PECD Quick-01 are polyether tray impression materials of medium-bodied consistency. They are designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™.
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K Number
K072055Device Name
LAVA FRAME, LAVA FRAME SHADE
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2008-02-26
(215 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments.
The titanium connection for the abutment must meet the following dimensions:
- Overall cementation surface > 30 mm²
- Height of the head of the titanium interface from the shoulder > 2.8 mm
The following systems fulfill the above described specifications:
Co. Alitec Dental GmbH: Camlog Titanium base for Ceramic abutment. Abutment ø ≥ 4.3 mm
- Co. Alltec Dental GmbH: Camlog Titanium-base for Ceramic-abutment - Abutment a ≥ 4.3 mm
- Co. Dentsply Friadent GmbH: Friadent Cera Base
- Co. Neoss GmbH: Neo Link Neoss Mono Abutment Titanium; Neo Link Neoss Multi Abutment Titanium; Neo Link Neoss Mono Aesthetic Abutment Titanium; Neo Link Neoss Multi Aesthetic Abutment Titanium; Matrix Abutment Hex - Regular Mono Titan; Matrix Abutment Hex - Regular Multi Titan; Matrix Abutment Hex - Narrow Mono Titan; Matrix Abutment Hex - Narrow Multi Titan; Matrix Abutment C-Lect - Regular Mono Titan; Matrix Abutment, C-Lect - Regular Multi Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment ST - Mono Titan; Matrix Abutment ST - Mono Titan
Device Description
Lava™ abutment made from Lava™ Frame zirconia mill blanks and dyed with Lava™ Frame Shade is classified as cndosseous dental implant abutment (21 C.F.R. § 872.3630) because it is a prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Lava™ Frame and Lava™ Frame Shade are parts of the Lava™ system (K011394). Lava™ Frame Zirconia mill blanks are used for the fabrication of frameworks for allceramic restorations. The frameworks for onlays, inlays, veneers, crowns and bridges are designed and manufactured by CAD/CAM technology, whereas the CAM fabricated Lava™ Abutments made from Lava™ Frame Zirconia mill blanks will be designed by means of a traditional wax up technique. The wax up will be scanned (Lava™ Scan, K062493) and milled without any further design step in the CNC milling unit Lava™ Form. After milling, the abutments are dyed with one of the 7 Lavat 10 Frame Shade dyeing liquids as required to achieve the desired tooth color, then sintered. The dyed abutments are sintered using the specialized program of the Lava™ Therm sintering furnace.
The wax up designed abutment will be cemented to a titanium interface which will be subsequently screwed into the respective implant (e.g. Camlog, Altatec Biotechnologies).
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K Number
K073296Device Name
TEMPXN28
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2008-01-09
(47 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
Device Description
TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.
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K Number
K071131Device Name
UNO
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2007-07-25
(93 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
3M ESPE AG DENTAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- All classes of fillings (according to Black) with lightcuring composite or compomer
- Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE
- Core build-ups made of light-curing composite
- Root surface desensitization
- Repair of composite or compomer fillings
- Repair of restorations veneered with composite or ceramic
- Bonding orthodontic appliances to teeth for orthodontic treatment
Device Description
Uno is classified Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Uno offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Uno is well suited for bonding methacrylate based composites to dentin and enamel. Uno is also indicated to seal sensitive root surfaces as is Adper Prompt L-Pop. Furthermore, Uno is suited to bond orthodontic appliances to teeth for orthodontic treatment as is Prompt L-Pop. Like Adper Prompt L-Pop, Uno will be available in single dose applicators and in a vial version.
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