(106 days)
IvoBase CAD for Zenotec, IvoBase CAD Bond and Modelling Liquid is a system used. For the fabrication of removable dentures,e.g .: - . partial and complete denture prosthetics - . hybrid denture prosthetics - . combined denture prosthetics - . mouthguards - implant-supported denture prosthetics .
use industrially polymerized disc made primarily from PMMA. The denture base disc is milled using the CAD/CAM technique to form the base of a partial, full denture or mouthguard. Commercially available preformed denture teeth are then bonded to the denture base using lvoBase CAD Bond and IvoBase CAD Modelling Liquid.
The provided document is a 510(k) Summary for a dental device, IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of acceptance criteria and device performance in the context of an AI/ML device.
Therefore, many of the requested items, such as specific acceptance criteria for AI algorithms, sample sizes for test sets in a machine learning context, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or cannot be extracted from this type of document.
However, I can provide the available information relevant to the device's testing and comparison to predicates, framed as closely as possible to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the standards and predicate device comparisons rather than explicitly listed with numerical targets. The "reported device performance" is a statement of substantial equivalence to the predicate based on these tests.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Properties (Denture Base) | Comparable to EN ISO 20795-1:2013 for powder/liquid materials, specifically for ultimate flexural strength, flexural modulus, maximum stress intensity factor, total fracture work, residual MMA, water sorption (7 days), and solubility (7 days). | Material was tested in accordance with EN ISO 20795:2013 for the specified parameters. (Specific values not provided, but deemed "substantially equivalent" to predicate based on these tests). |
| Mechanical Properties (Bond Materials) | Comparable to predicate device Probase Cold (K913655) for water sorption and solubility. | IvoBase Bond materials were tested for water sorption and solubility and found to be "comparable" with the predicate device. |
| Bonding Quality (Teeth to Denture Base) | Cohesive fracture when tested in accordance with EN ISO 22112:2005 Dentistry: Artificial Teeth for dental prosthesis. | A "cohesive fracture" was verified, indicating strong bonding. |
| Biocompatibility | Meet requirements of ISO 10993 and ISO 7405 for Dentistry; no cytotoxicity or genotoxicity; low irritation and sensitization risks. | Tests showed "no cytotoxic or genotoxic results." Irritation and sensitization risks "found to be low." Overall "equivalent to the predicate" based on assessment. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify sample sizes for mechanical or biocompatibility tests, nor does it refer to "test sets" in the context of data used for AI/ML validation. The data provenance is not mentioned beyond the fact that testing was conducted for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and testing. This is a medical device clearance submission for a dental material, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a dental material, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth or reference standard for testing was established through:
- Compliance with international standards (EN ISO 20795-1:2013, EN ISO 22112:2005, ISO 10993, ISO 7405).
- Comparison to legally marketed predicate devices' known properties and performance.
- Laboratory testing results (e.g., verification of cohesive fracture, lack of cytotoxicity).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning and therefore has no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13. 2015
Ivoclar Vivadent, Incorporated Donna Marie Hartnett, Esq. Director QA/Regulatory Affairs 175 Pineview Drive Amherst, New York 14228
Re: K151142
Trade/Device Name: IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI, MQC Dated: May 19, 2015 Received: May 20, 2015
Dear Ms. Hartnett:
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. 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.
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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151142
Device Name
IvoBase CAD for Zenotec, IvoBase CAD Bond and Modelling Liquid
Indications for Use (Describe)
IvoBase CAD for Zenotec. IvoBase CAD Bond and Modelling Liquid is a system used.
For the fabrication of removable dentures,e.g .:
- . partial and complete denture prosthetics
- . hybrid denture prosthetics
- . combined denture prosthetics
- . mouthguards
- implant-supported denture prosthetics .
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K
IvoBase CAD for Zenotec ar lvoBase CAD Bond and Modelling Liquid
Image /page/3/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" written below. Above the company name is a series of green and blue dots and squares arranged in an arc shape. The logo is clean and modern, reflecting the company's focus on innovation in the dental industry.
| Contact: | Donna Marie HartnettIvoclar Vivadent, Inc., 175 Pineview Drive, Amherst, NY 14228 | |
|---|---|---|
| Company: | Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535 | |
| Date Prepared: | August 12, 2015 | |
| Proprietary Name: | IvoBase CAD for Zenotec andIvoBase CAD Bond and Modelling Liquid | |
| Classification Name: | Resin, Denture, Relining, repairing, rebasing (872.3760) – Class IIClassification Code EBI | |
| Predicate Devices: | IvoBase CAD for Zenotec is substantially equivalent to:(Primary Predicate) - M-PM-Disc (Pink) (K140758) marketed by Merz Dental GmbH.- SR Ivocap Plus (K915377) manufactured by Ivoclar Vivadent, AG- Probase Hot and Cold (K913655)- Ivobase Hybrid, Ivobase High Impact (K103391)both manufactured by Ivoclar Vivadent, AG. |
Device Description: use industrially polymerized disc made primarily from PMMA. The denture base disc is milled using the CAD/CAM technique to form the base of a partial, full denture or mouthguard. Commercially available preformed denture teeth are then bonded to the denture base using lvoBase CAD Bond and IvoBase CAD Modelling Liquid.
Traditionally dentures have been made by preparing a dough from polymer powder and monomer liquid which is then polymerized using heat. The new aspect of IvoBase CAD for Zenotec is that this dough is industrially polymerized and ready-to-use for the dental technician. CAD/CAM technology is used to design and mill the denture instead of preparing a model and using the lost-wax technique.
The advantaqe of the new working technique is that polymerization shrinkaqe has already taken place and therefore the accuracy of the denture can be expected to be improved. Additionally, the dental technician can use the CAD/CAM technique which is now routine for dental laboratory procedures. Because the end prosthesis is the same as one created using historic
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510(K) SUMMARY
(Revised 8.12.15) IvoBase CAD for Zenotec and lvoBase CAD Bond and Modelling Liquid
Image /page/4/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" written below. Above the company name are a series of green and blue dots and squares. The logo is clean and modern, and the colors are bright and inviting.
lost-wax technique, there are no new issues of safety and effectiveness created by the device which is the subject of this submission.
Intended Use:
IvoBase CAD for Zenotec, IvoBase CAD Bond and Modelling Liquid is a system used:
For the fabrication of removable dentures,e.g.:
- partial and complete denture prosthetics ●
- hybrid denture prosthetics
- combined denture prosthetics
- mouthguards
- implant-supported denture prosthetics ●
Comparison to predicate
| Predicate DeviceM-PM-Disc (Pink) (K140758)(unless otherwise noted) | Subject Device | |
|---|---|---|
| Indications | M-PM-Disc (Pink) (K140758) Device forfabrication of dental bases for removabledentures.Ivocap High Impact (K915377) is used for:- Complete dentures- Partial dentures- Bases and relines- Orthodontic appliances- Bite guard splints | IvoBase CAD for Zenotec is used for thefabrication of:- Partial and complete dentureprosthetics- Combined denture prosthetics- Implant-supported prosthetics- Hybrid prosthetics- Mouthguards |
| CAD CAMTechnology | M-PM-Disc (Pink) (K140758) - pink PMMAdisc intended for use in the fabrication ofdenture bases using CAD CAM technology | IvoBase CAD for Zenotec is a PMMAdisc intended for use in the fabrication ofdenture prosthetics using CAD CAMTechnology. |
| Monomer/polymer form | M-PM-Disc (Pink) (K140758) PMMA materialin disc form with denture formed using CADCAM Technology.IvoBase Hybrid, IvoBase High Impact(K103391) is presented as a polymer powderand monomer liquid which are sold in pre-dosed capsules. The material is automaticallymixed using the appropriate equipment(Ivocap machine). The mixed acrylic isinjected into the prepared form containing theprosthetic denture teeth. The material ispolymerized using heat. Final adjustmentsare then made. | The denture base is formed using CADCAM technology. The prosthetic dentureteeth are then bonded to the denturebase using IvoBase CAD Bond andIvoBase CAD Modelling Liquid. IvoBaseCAD Bond consists of a powder polymerand monomer liquid similar to atraditional denture base device. |
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510(K) SUMMARY (Revised 8.12.15) IvoBase CAD for Zenotec and lvoBase CAD Bond and Modelling Liquid
Image /page/5/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the words "ivoclar vivadent" in blue, with the "i" in "ivoclar" being green. Above the words are a series of green and blue dots arranged in an arc. Below the words is the phrase "passion vision innovation" in a smaller font.
| Principles ofoperation | Step-by-step: | Step-by-step: |
|---|---|---|
| - Anatomical impression- Lab makes plaster model andindividual tray- Impression and bite registration- Lab makes plaster master modeland wax try-in- Try-in and functional check- Lab sets teeth, embeds in mold,boils out wax and replaces withdenture base resin.- After curing final adjustments andpolishing- Insertion | - Anatomical impression and pre-bite registration- Lab makes scan of impressionand mills individual tray- Functional impression and biteregistration- Lab makes scan and mills try-inbody (Tray Disc for Zenotec)- Try-in and esthetic, functionalcheck- Lab makes final denture.- IvoBase CAD for Zenotec canbe processed using the Zenotecselect milling machine. First thelingual side is milled, then theteeth are bonded in positionusing ivoBase CAD Bond andthen the basal side is milled.- After milling, the denture base isseparated from the disc, shapeadjustments are made and thenit is polished.- Insertion | |
| Composition | Traditional PMMA Polymer/monomerdenture base material with pigmentation forshade | The chemical composition of the newproduct and predicate are the same,except for small changes in pigmentsand the fact that the disc product isindustrially polymerized. Thereforecertain ingredients (the methylmethacrylate and initiators) are no longerpresent. The result of thebiocompatibility assessment is that theproduct is equivalent to the predicate. |
The comparison shows that IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid is substantially equivalent to the predicate device.
Technological Characteristics: The basic process for the dentist remains the same however the dental technician mills the denture using CAD/CAM technology instead of using the lost-wax technique. The product is supplied as a polymerized disc instead of powder/liquid to be mixed and cured. The bonding process of the denture teeth is new as traditionally denture teeth are set using a heat or self curing process after mixing a powder and monomer liquid into a dough. The finished device is intended to operate the same as the predicate.
Testing Summary:
- EN ISO 20795-1:2013 Dentistry Base Polymers Part 1: Denture base polymers (ISO ● 20795-1:2013) does not directly apply because the scope of this standard covers
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510(K) SUMMARY (Revised 8.12.15) IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid
Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar Vivadent" in a stylized font. The words "passion vision innovation" are written in smaller letters below the main logo. There are green and blue dots above the logo.
powder and liquid material which are mixed together and polymerized. IvoBase CAD for Zenotec is supplied as a ready-to-use disc which has been industrially polymerized. However this standard contains elements which are relevant for the verification of lvoBase CAD for Zenotec and the material was tested in accordance with EN ISO 20795:2013 for Ultimate flexural strength, Flexural modulus, Maximum stress intensity factor, Total fracture work, Residual MMA, Water sorption (7 days), and Solubility (7 days).
- IvoBase Bond materials were tested for water sorption and solubility and found to be ● comparable with the predicate device Probase Cold (K913655).
- . The quality of the bonding of synthetic polymer denture teeth to IvoBase CAD for Zenotec using IvoBase CAD Bond was tested in accordance with EN ISO 22112:2005 Dentistry: Artificial Teeth for dental prosthesis and a cohesive fracture was verified.
- . When compared to the predicate device, the physical properties and bonding of the subject device are substantially equivalent.
Biocompatibility:
- Biocompatibility testing and evaluation was carried out according to ISO 10993 and ISO ● 7405 for Dentistry.
- . The polymerized disc and Bond materials were tested for cytotoxicity and genotoxicity and the results showed no cytotoxic or genotoxic results.
- Subchronic systemic toxicity testing was not conducted due to the low water solubility of ● the subject device.
- . Irritation and sensitization risks were evaluated and found to be low, based on comparison to comparable devices.
- The chemical composition of the new product and predicate are the same, except for . small changes in pigments and the fact that the disc product is industrially polymerized. Therefore certain ingredients (the methyl methacrylate and initiators) are no longer present.
- . The result of the biocompatibility assessment is that the subject device is equivalent to the predicate.
CONCLUSION: The above data and analysis demonstrates that IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid is substantially equivalent to the predicate device.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.