Search Results
Found 6 results
510(k) Data Aggregation
K Number
K222686Device Name
Perfit FS Dental Zirconia Fully Sintered Block
Manufacturer
Date Cleared
2022-10-06
(30 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Vatech Acucera, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Device Description
The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre shaded, fully sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit FS Dental Zirconia Fully Sintered Block are zirconia oxide block made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the Zr02 so that its final properties can be achieved.
They are available in different models that differ in various specification and color. There are white zirconia products(White) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, White) color products , Shade multi-layer(ML A1/A2/A3, A1M, A2M, A3M, A3.5M, A4M, B1M, B2M, B3M, B4M, C1M, C2M, C3M, C4M, D2M, D3M, D4M) color products.
The white zirconia is composed of Zr02+Y203+Nb205 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 and other oxide. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs that matches natural color of patient's teeth.
The composition of the Dental Zirconia Block including the white zirconia and the color zirconia conforms to ISO 13356:2015. Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
Ask a Question
Ask a specific question about this device
K Number
K203590Device Name
Perfit FS Dental Zirconia Fully Sintered Block
Manufacturer
Date Cleared
2021-06-24
(198 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Vatech Acucera, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Device Description
The Perfit FS Dental Zirconia Fully Sintered Block consists of zirconium oxide which compresses ceramic for milling, grinding. It is a preshaded, fully sintered product and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc. The Perfit FS Dental Zirconia Fully Sintered Block are zirconia oxide block made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. They are available in different models that differ in various specification and color. There are white zirconia products(White) and colored zirconia products, and colored zirconia is also divided into Monolaver(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products , Shade multi-laver(ML A1/A2/A3, A1M, A2M, A3.5M, A4M)color products. The white zirconia is composed of Zr02+Y203+Nb205 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 and other oxide. The composition of the Dental Zirconia Block including the white zirconia and the color zirconia conforms to ISO 13356:2015. Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
Ask a Question
Ask a specific question about this device
K Number
K203499Device Name
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
Manufacturer
Date Cleared
2021-04-05
(129 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Vatech acucera, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Device Description
The Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products , Shade multi-layer(A1 SM, A2 SM, A3 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products and Trans&Shade multi-layer(A1 TM, A2 TM, A3 TM, A3 TM, A4 TM, B1 TM, B2 TM, B3 TM, B4 TM, C1 TM, C2 TM, C3 TM, C4 TM, D2 TM, D3 TM, D4 TM) color products.
The white zirconia is composed of ZrO2+HfO2+Y2O3 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 +Pr203 +Er203. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.
The composition of the Dental Zirconia Blocks including the white zirconia and the color zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
Ask a Question
Ask a specific question about this device
K Number
K203351Device Name
Perfit ZR HT Dental Zirconia blank
Manufacturer
Date Cleared
2021-03-08
(115 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Vatech acucera, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perfit ZR HT Dental Zirconia blank are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Device Description
The Perfit ZR HT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit ZR HT Dental Zirconia blank are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products and multi-layer(A1 SM, A2 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products.
The white zirconia is composed of Zr02+HfO2+Y2O3 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 +Pr203 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.
The composition of the Dental Zirconia Blocks including the white zirconia and the color zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
Ask a Question
Ask a specific question about this device
K Number
K070045Device Name
ZIRBLANK-PS AND ZIRBLANK-FS
Manufacturer
Date Cleared
2007-03-26
(81 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
ACUCERA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
Device Description
Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.
Ask a Question
Ask a specific question about this device
K Number
K051501Device Name
ZIRACE
Manufacturer
Date Cleared
2005-10-19
(135 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ACUCERA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ZirAce™ abutments are indicated for use in partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function. They are especially applicable to anterior or canine teeth where the typical titanium color may show through the gum. In addition to the Branemark (Nobel Biocare) implants, the ZirAce™ abutments hexagon connector fits the external hexagon of the following implants:
- . 3i ,
- Lifecore Biomedical , .
- Sterngold Implamed. .
Device Description
ZirAce "" is a ccramic abutment composed of zirconium oxide stabilized with yttrium oxide, and containing niobium oxide to improve the properties and color. The zirconium oxide stabilized with yttrium oxide ceramic has been used for about 25 years as hip-implant and other prostheses and is capable of machining by modern CAD-C'AM methods. Various versions of this ceramic have been cleared for dental uses as inlays onlays and vencers by Dentronic in K971414 and for such materials and crowns and copings by Cynovad in K033227 and Medin Tech in K043472. The material is radio-opaque, for ready visualization.
Ask a Question
Ask a specific question about this device
Page 1 of 1