(148 days)
Not Found
No
The device description and performance studies focus on the material properties and compliance with ISO standards for dental ceramics, with no mention of AI or ML.
No
The device is a dental ceramic system used to create all-ceramic restorations and is not directly involved in treating or alleviating a disease or condition.
No
The device is a dental ceramic system used to create all-ceramic restorations and to finish dental restorations, not to diagnose medical conditions.
No
The device description clearly states it comprises "pressable ingots and compatible layering ceramic powders," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental restorations (veneers, crowns, bridges, etc.) for the anterior and posterior tooth region. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a dental ceramic system used by dental technicians in a laboratory setting to fabricate physical dental prosthetics. It's a material used in the creation of a medical device, not a device that performs a diagnostic test on a biological sample.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on the physical and chemical properties of the ceramic material (flexural strength, solubility, thermal expansion, etc.), which are relevant to its use as a dental restorative material, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The indications for use for Livento® press, Soprano® 10 and Soprano® are:
-Veneers
-Inlays and onlays
-Partial crowns
-Anterior and posterior tooth crowns
-Hybrid abutment crown
- -3-pontic bridge in anterior tooth region
-3-pontic bridge in the premolar region up to max. 2nd premolar as a permanent abutment
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The Livento/Soprano dental ceramic system comprise pressable ingots and compatible layering ceramic powders used in dental laboratories by the dental technician to create all ceramic restorations.
Livento® press is a pressable lithium disilicate glass-ceramic supplied in ingots of 3 grams. The material is supplied in different levels of translucency (MT, LT, ET, HQ, Opal and Bleach) each in different dental shades of Vita A, B, C and D.
Soprano® 10 is a layering fluorapatite glass-ceramic supplied as powder suitable for veneering substructures made from Livento® press lithium disilicate glass-ceramic and zirconium oxide. It has a range of different translucency levels (Frame Modifier, Opaque Dentine, Incisal/Enamel, Transparent, Clear) and is available in the Vita classic colors A, B, C and D as well as Bleach shades and Modifiers.
Soprano® shades, stains and glaze are glass ceramic dental porcelain material. They are intended to finish dental restorations and are offered in a variety of shades.
All Livento/Soprano dental ceramics meet the requirements of ISO 6872:2015.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior tooth region, premolar region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental laboratories by the dental technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This 510(k) submission includes the results of performance testing supporting compliance to International Standard ISO 6872:20015 as recognized by FDA. Measured parameters in a representative sample of the products included:
- Flexural strength,
- Chemical Solubility, .
- Coefficient of Thermal Expansion, .
- Glass Transition Temperature, and
- Radioactivity of 238U. .
The results show product compliance to the requirements of ISO 6872:2015.
The Livento/Soprano dental ceramics are surface contacting materials with contact with the oral mucosa with contact duration of more than 30 days (permanent contact). Biocompatibility evaluation was based on the similarity with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2020
Cendres+Metaux SA Andrea Sparti Regulatory Affairs Manager Rue de Boujean 122 Biel/Bienne, 2501 SWITZERLAND
Re: K192251
Trade/Device Name: Livento© Press, Soprano 10©, Soprano© Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 27, 2019 Received: October 17, 2019
Dear Andrea Sparti:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192251
Device Name
Livento® press, Soprano® 10, Soprano®
Indications for Use (Describe)
The indications for use for Livento® press, Soprano® 10 and Soprano® are:
-Veneers
-Inlays and onlays
-Partial crowns
-Anterior and posterior tooth crowns
-Hybrid abutment crown
- -3-pontic bridge in anterior tooth region
-3-pontic bridge in the premolar region up to max. 2nd premolar as a permanent abutment
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized letter "M" on the left, followed by the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. The text is in a simple, sans-serif font, and the plus sign is slightly raised.
510(k) Summarv
510(k) number: K192251
Submitter
CENDRES+METAUX SA Rue de Boujean 122 CH-2501 Biel / Bienne Switzerland
Phone : +41 58 360 20 00 Fax :+41 58 360 20 10
Contact Person: Andrea Sparti Date prepared: 15 January 2020
Device
Trade Name: Livento® press, Soprano® 10 and Soprano® Common Name: Dental ceramic Classification Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Regulation Number: 21 CFR 872.6660
Primary Predicate Device
DCceram System 510(k) number: K141400
Device Description
The Livento/Soprano dental ceramic system comprise pressable ingots and compatible layering ceramic powders used in dental laboratories by the dental technician to create all ceramic restorations.
Livento® press is a pressable lithium disilicate glass-ceramic supplied in ingots of 3 grams. The material is supplied in different levels of translucency (MT, LT, ET, HQ, Opal and Bleach) each in different dental shades of Vita A, B, C and D.
Soprano® 10 is a layering fluorapatite glass-ceramic supplied as powder suitable for veneering substructures made from Livento® press lithium disilicate glass-ceramic and zirconium oxide. It has a range of different translucency levels (Frame Modifier, Opaque Dentine, Incisal/Enamel, Transparent, Clear) and is available in the Vita classic colors A, B, C and D as well as Bleach shades and Modifiers.
Soprano® shades, stains and glaze are glass ceramic dental porcelain material. They are intended to finish dental restorations and are offered in a variety of shades.
All Livento/Soprano dental ceramics meet the requirements of ISO 6872:2015.
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Image /page/4/Picture/0 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized letter "C" on the left, followed by the text "CENDRES+" on the top line and "MÉTAUX" on the bottom line. The text is in a simple, sans-serif font, and the entire logo is in black against a white background.
Indication for Use
- Veneers ●
- Inlays and onlays ●
- Partial crowns ●
- Anterior and posterior tooth crowns
- Hybrid abutment crown ●
- 3-pontic bridge in anterior tooth region .
- 3-pontic bridge in the premolar region up to max. 2nd premolar as a permanent abutment .
Comparison of Technological Characteristics with the Primary Predicate Device
The legally marketed device to which CENDRES+METAUX SA is claiming equivalence is identified as DCceram System, K141400, manufactured by Ceramay GmbH & Co. KG. The DCceram System is comprised of pressable silica-based ceramic pellets and compatible layering porcelains powders used to create all-ceramic restorations.
Specifically, equivalence is claimed between the following products:
- DCceram Concept press & Livento® press ●
- DCceram 9.2 & Soprano® 10 .
- . DCceram Concept Art stains, shades and glazes & Soprano® Flu-Stains, Flu-Shades and Glazes.
Substantial equivalence is based on indications for use, technological characteristics, material composition, and conformity with consensus standards.
The comparison of the candidate device to the predicate device shows that, when looking at comparable constituents, the devices have the same intended use:
- Manufacture of all-ceramic crowns and bridges by the press technique for DCceram -Concept press and Livento® press
- । Layering the pressed ceramic crown or bridge or a zirconium oxide framework for DCceram 9.2 and Soprano® 10
- Staining lithium disilicate glass ceramic or zirconium oxide in its final shades for -ConceptArt and Soprano® Stains, shades and glazes
The indications are comparable, including veneers, inlays and onlays, partial and full crowns and 3-unit bridges in the anterior and premolar regions with the same limitations of including the second pre-molar as a terminal abutment.
The devices are made of the same materials:
- Silicate glass ceramic mainly composed of SiO2, Al2O3, Li2O, P2O5, K2O, CaO, B2O3 -
The measured parameters according to ISO 6872 show slight differences between the subject device and the predicate. However, none are of clinical significance. Both devices conform to the consensus standard ISO 6872, which provides performance specifications satisfied by both the predicate and the candidate device.
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Image /page/5/Picture/0 description: The image shows the logo for Cendres+Metaux. The logo consists of a stylized letter "C" on the left, followed by the words "CENDRES+" on the top line and "MÉTAUX" on the bottom line. The text is in a simple, sans-serif font and is all black.
Performance Data
This 510(k) submission includes the results of performance testing supporting compliance to International Standard ISO 6872:20015 as recognized by FDA. Measured parameters in a representative sample of the products included:
- Flexural strength, ●
- Chemical Solubility, .
- Coefficient of Thermal Expansion, .
- Glass Transition Temperature, and ●
- Radioactivity of 238U. .
The results show product compliance to the requirements of ISO 6872:2015.
The Livento/Soprano dental ceramics are surface contacting materials with contact with the oral mucosa with contact duration of more than 30 days (permanent contact). Biocompatibility evaluation was based on the similarity with the predicate device.
Conclusions
Based on the above, we conclude that Livento/Soprano dental ceramics are substantially equivalent to the predicate device DCceram System.