(195 days)
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device is a chemical bonding agent.
No.
The device is a bonding agent used to fix prosthetic teeth, not to treat or diagnose a medical condition.
No
This device is a two-component glue used to fix custom-fit prosthetic teeth in dental bases, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that VITA VIONIC® Bond is a two-component glue composed of acrylate polymers, which are physical substances, 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 "fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases." This is a mechanical function for assembling a dental prosthesis.
- Device Description: The device is a "two-component glue" used to "fix artificial teeth in the milled denture base." This describes a bonding agent for dental prosthetics.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat any medical condition by examining samples from the human body. IVDs are used to perform tests on biological specimens (like blood, urine, tissue) to provide information about a person's health.
Therefore, VITA VIONIC® Bond is a dental material used in the fabrication of dentures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VITA VIONIC Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.
Product codes
EBI
Device Description
VITA VIONIC® Bond is a two-component glue, mainly composed of acrylate polymers based on methyl methacrylate and used to fix artificial teeth in the milled denture base. VITA VIONIC® component I comes in a glass jar with a screw top lid and VITA VIONIC® Bond component II comes in a glass bottle with a screw top cap. Component II is mixed into component I by stirring until no streaks are visible. A thin film is then applied to all Bonding surfaces and then the artificial teeth are placed into the denture base and VITA VIONIC® Bond is allowed to cure. Comes in one, colorless shade.
This product is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench test results allowed us to conclude that VITA VIONIC® Bond is substantially equivalent to the predicate device for its intended use.
A biocompatibility assessment was performed on VITA VIONIC® Bond in accordance with ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 - Dentistry -Evaluation of Biocompatibility of Medical Devices Used in Dentistry. This assessment supports that VITA VIONIC® Bond is biocompatible and concludes that the device is substantially equivalent to the predicate device for its intended use based on the following:
Biocompatibility tests were conducted on VITA VIONIC Bond for cytotoxicity, sensitization, irritation and intracutaneous reactivity, and genotoxicity.
- Cytotoxicity and genotoxicity and the results showed no cytotoxic or genotoxic results
- Irritation and sensitization risks were evaluated and found to be low
No human clinical testing was performed to support the substantial equivalence of VITA VIONIC® Bond.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 29, 2020
VITA Zanhnfabrik H. Rauter GmbH Co. % Lindsay Tilton Regulatory Affairs & Compliance (Consultant) VITA North America 22705 Savi Ranch Parkway, Sutie 100 Yorba Linda. California 92887
Re: K191926
Trade/Device Name: VITA VIONIC Bond Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: December 20, 2019 Received: December 30, 2019
Dear Lindsay Tilton:
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
1
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name VITA VIONIC Bond
Indications for Use (Describe)
VITA VIONIC Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.
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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K191926 510(k) Summary
| Submitter | VITA Zahnfabrik H.Rauter GmbH Co.
Spitelgasse 3
Bad Sackingen, D-79713
Germany
Establishment Reg. No. 1000625496 | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact | Bernd Walker
Head of Regulatory Affairs and Quality Systems
Phone (+49) 7761 562-361
Fax (+49) 7761 562-384
B.Walker@vita-zahnfabrik.com | |
| Official Correspondent | Lindsay Tilton
Regulatory Affairs & Compliance Manager
VITA North America, Inc.
22705 Savi Ranch Parkway, Suite 100
Yorba Linda, CA 92887
Establishment Reg. No. 2082832
Phone (925) 699-9091
E-mail: ltilton@vitanorthamerica.com | |
| Date Prepared | January 24, 2020 | |
- Trade/Device Name VITA VIONIC® Bond
- י Classification Name Denture relining, repairing, or rebasing resin
- . Regulation Number 21 CFR 872.3760
- Product Code EBI
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Predicate and Reference Predicate Devices
lvoBase CAD Bond, and Modelling Liquid – K151142 – Primary Predicate Device
Tokuyama Curegrace – K170549 – Reference Predicate Device
Device Description
VITA VIONIC® Bond is a two-component glue, mainly composed of acrylate polymers based on methyl methacrylate and used to fix artificial teeth in the milled denture base. VITA VIONIC® component I comes in a glass jar with a screw top lid and VITA VIONIC® Bond component II comes in a glass bottle with a screw top cap. Component II is mixed into component I by stirring until no streaks are visible. A thin film is then applied to all Bonding surfaces and then the artificial teeth are placed into the denture base and VITA VIONIC® Bond is allowed to cure. Comes in one, colorless shade.
This product is provided non-sterile.
Indications for use
VITA VIONIC® Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.
Material Composition
VITA VIONIC® Bond is mainly composed of acrylate polymers based on methyl methacylate (MMA)
Non-Clinical Performance Testing
VITA VIONIC® Bond was evaluated according to the following FDA recognized standards:
- . DIN EN ISO 20795-1:2013 - Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013)
- o This standard mainly refers to the requirements for a denture base. VITA VIONIC® Bond, bonds the artificial teeth to the denture base, which is tested under section 8.7 "Bonding to synthetic polymer teeth"
- Section 8.9: Water solubility and water sorption
- ISO 10993-1:2009 - Biological evaluation of medical devices
- I ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices
- . A Chemical Analysis was conducted on VITA VIONIC® Bond and the Residual monomer content were found to be below the limit values.
5
Bench test results allowed us to conclude that VITA VIONIC® Bond is substantially equivalent to the predicate device for its intended use.
Biocompatibility
A biocompatibility assessment was performed on VITA VIONIC® Bond in accordance with ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 - Dentistry -Evaluation of Biocompatibility of Medical Devices Used in Dentistry. This assessment supports that VITA VIONIC® Bond is biocompatible and concludes that the device is substantially equivalent to the predicate device for its intended use based on the following:
Biocompatibility tests were conducted on VITA VIONIC Bond for cytotoxicity, sensitization, irritation and intracutaneous reactivity, and genotoxicity.
- I Cytotoxicity and genotoxicity and the results showed no cytotoxic or genotoxic results
- . Irritation and sensitization risks were evaluated and found to be low
Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA VIONIC® Bond.
| | Subject Device | Primary Predicate
Device | Reference Predicate
Device |
|-----------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Device Name | VITA VIONIC® Bond | IvoBase Bond and
Modelling Liquid | Tokuyama Cure
Grace |
| Device Classification | Denture relining,
repairing, or
rebasing resin | Denture relining,
repairing, or
rebasing resin | Denture relining,
repairing, or
rebasing resin |
| Product Code | EBI | EBI | EBI,EBG |
| Indication for use | Used to fix custom-
fit prosthetic teeth
in appropriately
milled cavities of
prosthetic bases | For the fabrication
of removable
dentures, e.g.:
-partial and
complete denture | An acrylic resin used
in a variety of
dental application
such as:
-Temporary inlay, |
Comparison to Predicate Devices
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| prosthetics | crowns and bridges | ||
|---|---|---|---|
| Hybrid denture | |||
| prosthetics | -Repair of broken or | ||
| cracked dentures | |||
| -Combined denture | |||
| prosthetics | -Denture border | ||
| extension | |||
| -Mouth guards | -Replacement of | ||
| lost denture teeth | |||
| -Implant-supported | |||
| denture prosthetics | -Adjustment of | ||
| occlusal height of | |||
| resin teeth | |||
| Components | Liquid and Liquid | Powder and Liquid | Powder and Liquid |
| Principle of | |||
| operation | Cured by chemical | ||
| polymerization | |||
| reaction starting | |||
| with mixing the | |||
| liquid and liquid | |||
| component. (Self- | |||
| curing) | Cured by chemical | ||
| polymerization | |||
| reaction starting | |||
| with mixing the | |||
| powder and liquid | |||
| component. (Self- | |||
| curing) | Cured by chemical | ||
| polymerization | |||
| reaction starting | |||
| with mixing the | |||
| powder and liquid | |||
| component. (Self- | |||
| curing) |
Conclusion
Information provided in this application demonstrates that VITA VIONIC® Bond is substantially equivalent to the predicate devices.