(159 days)
No
The 510(k) summary describes a light-curing stain/glaze system for dental restorations and does not mention any AI or ML components.
No
The device is a light-curing stain/glaze system for dental restorations, used for surface characterization, not for treating a disease or condition.
No
The device is a light-curing stain/glaze system for surface characterization of dental restorations, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "light-curing methacrylatebased stain/ glaze system," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for extraoral surface characterization and internal characterization of dental restorations. This involves working with materials used outside the body to create or modify dental prosthetics.
- Device Description: The device is a stain/glaze system for dental restorations. This is a material applied to dental devices, not a test performed on biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health or condition. IVDs are specifically designed for this purpose.
The device is clearly intended for use in a dental laboratory or clinical setting to enhance the appearance and properties of dental restorations, which are medical devices themselves, but the stain/glaze system is not an IVD.
N/A
Intended Use / Indications for Use
VITA AKZENT LC Indication range:
- Restorations made of hybrid ceramic
- · Restorations made of light-curing veneering material
- · Restorations made of CAD/CAM composites
- · Prefabricated Teeth
- · Denture bases
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
VITA Akzent® LC VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
VITA Akzent® LC meets the applicable requirements of the following FDA recognized standards:
- . ISO 10993-1:2009 – Biological evaluation of medical devices
- I ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices
Biocompatibility:
A biocompatibility assessment was performed on VITA Akzent® AC 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 Akzent® LC is biocompatible and concludes that the device is substantially equivalent to the predicate device in terms of biocompatibility.
Clinical Performance Data:
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Akzent® AC.
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.
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
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
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November 22, 2021
VITA Zahnfabrik GmbH H Rauter & Co % Lindsay Tilton Regulatory Affairs Consultant VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887
Re: K211854
Trade/Device Name: VITA Akzent LC Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material For Resin Fillings Regulatory Class: Class II Product Code: EBD Dated: August 25, 2021 Received: August 27, 2021
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
1
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 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 (QS) 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 medical devices and radiation-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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K211854
Device Name VITA Akzent LC
Indications for Use (Describe)
VITA AKZENT LC Indication range:
- Restorations made of hybrid ceramic
- · Restorations made of light-curing veneering material
- · Restorations made of CAD/CAM composites
- · Prefabricated Teeth
- · Denture bases
| 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) Summary
K211854
| 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 System
Phone (+49) 7761 562-361
Fax (+49) 7761 562-384
B.Walker@vita-zahnfabrik.com |
| Official Correspondent | Lindsay Tilton
Regulatory Affairs Consultant
VITA North America, Inc.
22705 Savi Ranch Parkway, Suite 100
Yorba Linda, CA 92887
Establishment Reg. No. 2082832
Phone (800) 828-3839
Fax (714) 221-6759
E-mail: Itilton@vitanorthamerica.com |
Date Prepared
November 16,2021
- י Trade/Device Name Vita Akzent® LC
- י Classification Name Coating Material for Resin Filling
- Regulation Number 21 CFR 872.3310
- י Product Code EBD
Predicate Devices
Vident's VITA Enamic Stains– K123761 – Primary Predicate Device
4
GC America's Optiglaze - K133836 - Reference Device
Device Description
VITA Akzent® LC VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.
Indications for Use
VITA AKZENT LC Indication range:
- Restorations made of hybrid ceramic
- Restorations made of light-curing veneering material
- Restorations made of CAD/CAM composites
- Prefabricated Teeth
- Denture bases
Technological Characteristics
VITA Akzent® LC provides a light cured glaze system similar to the predicate device formulas. The composition of the VITA Akzent®LC and the predicates are based on similar materials, therefore this difference does not impact the substantial equivalence.
Non-Clinical Performance Testing
VITA Akzent® LC meets the applicable requirements of the following FDA recognized standards:
- . ISO 10993-1:2009 – Biological evaluation of medical devices
- I ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices
Biocompatibility
A biocompatibility assessment was performed on VITA Akzent® AC 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 Akzent® LC is biocompatible and concludes that the device is substantially equivalent to the predicate device in terms of biocompatibility.
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Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Akzent® AC.
Comparison to Predicate Devices
Below is a table showing the predicate device comparison.
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| Device Name | VITA Akzent® LC - K211854 | Vident's VITA Enamic | |
| Stains- K123761 | GC America's Optiglaze |
- K133836 |
| Device Classification | Coating, Filling Material,
Resin | Coating,Filling Material,
Resin | Coating,Filling
Material, Resin |
| Product Code | EBD | EBD | EBD |
| Indication for use | VITA AKZENT LC Indication
range:
• Restorations made of
hybrid ceramic
• Restorations
made of light curing
veneering material
• Restorations made of
CAD/CAM
Composites
• Prefabricated
Teeth
• Denture bases | VITA Enamic Stains are
indicated for shade
customization and
characterization of the
surface of dental
restorations made of
hybrid ceramic-resin and
resin materials. | For characterization
of direct and indirect
composite
restorations, acrylic
denture base and
artificial acrylic
teeth.
For obtaining surface
smoothness and
wear resistance of
restorations made of
composite
resin, acrylic denture
base and artificial
acrylic teeth. |
| Technological
Characteristics | Liquid | Powder and Liquid | Liquid |
| Principle of
operation | For characterization and
glazing restorations | For characterization and
glazing restorations | For characterization
and glazing
restorations |
| Material
composition | A mixture of | A mixture of | Multifuctional acrylate, |
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| methacrylates, initiators and
other non-hazardous | methacrylates, initiators
and other non-hazardous | methyl methacrylate,
silica
filler, photo initiator,
pigment |
|------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------|
| additions | additions | |
Differences between Subject and Predicate Devices
The predicate device indication for use was submitted with a more generic indication. Below is how the predicate device is similar in indications for Akzent LC.
The predicate device was designed states that it's intended for customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials. These terms are similar to the subject's device indication of Restorations made of hybrid ceramic, light-curing veneering material (resin materials), CAD/CAM composites (resin materials) and Denture bases (resin materials)
Both cover the same indications, and no additional indications are added to the subject device, therefore this does not affect the substantial equivalence or efficacy and safety.
The reference device was used since the subject device product is in liquid form as is the reference device. The primary predicate uses a liquid and a powder form. The same mechanism is used, and the subject device is considered a subset of the primary predicate device and equivalent to the reference device. Performance and biocompatibility testing prove that the subject device, in a liquid form, does not impact the safety and effectiveness of the product and shows. The adhesion performance testing conducted against the reference device, shows a more favorable efficacy during bench testing.
Conclusion
Based on the above comparative tables, it is concluded that VITA Akzent®LC is equivalent to the predicate device. VITA Akzent® LC has similar indications for use and similar material composition as the predicate devices.