(183 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical/thermal testing of a light-curing opaquer, with no mention of AI or ML.
No.
The device is a light-curing opaquer used to mask framework structures in dental restorations and is applied extraorally. It is a material component for veneering, not a device used for therapeutic purposes such as diagnosing, treating, or preventing disease, or affecting the structure or function of the body in a therapeutic way.
No
The device is a light-curing opaquer used to mask framework structures in dental restorations. It is a material used in the fabrication process, not for diagnosing a condition or disease.
No
The device description clearly indicates it is a physical paste stored in a syringe and applied with a brush, which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use is to "mask framework structures" for dental restorations (crowns, bridges, partial dentures). This is a material used in the fabrication of a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a light-curing paste applied to dental frameworks extraorally (outside the mouth) during the fabrication process. It's a component of a dental restoration, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on mechanical and thermal properties relevant to the material's function in a dental restoration, not on diagnostic accuracy.
In summary, the device is a material used in the creation of a dental prosthesis, which is a medical device, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Signum opaque F is a light-curing, one component opaquer used for extraoral color-masking of framework structures for crowns, bridges, and/or partial dentures. The veneering composites are processed by dental restoration by veneering framework-supported restorations, such as metal or zirconia frameworks.
Signum opaque F is a paste stored in a syringe featuring a plunger and a closing cap. The product is dispensed and is then applied with a disposable brush until the scaffolding frame is completely covered. After polymerization, the crown or bridge is inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted.
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)
Mechanical testing was performed in regard to testing shear bond strength. This testing was performed on various metal frameworks (i.e. non-precious metal, precious metal, zirconium dioxide, PEEK (high performance polymers)).
Thermal testing was performed in the shelf-life report, utilizing testing methods at differing temperatures.
All nonclinical testing was performed with conformity to applicable standards.
This clinical evaluation is based on internal data and scientific literature currently available about veneering composites and comparable medical devices. Veneering composites of Kulzer are marketed purpose without any hithout any hint for negative benefit-risk ratio. The final individualized medical devices, prepared in a conventional process, is well-established. Therefore, clinical investigation with veneering composites c&b is not necessary and the route for this clinical evaluation is literature based.
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 7, 2023
Kulzer, LLC David Vincent Director, QA/RA 4315 S. Lafayette Blvd South Bend, Indiana 46614
Re: K230644
Trade/Device Name: Signum opaque F Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 4. 2023 Received: August 4, 2023
Dear David Vincent:
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.
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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 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 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.
Michael E. Adjodha -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Signum opaque F
Indications for Use (Describe)
Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.
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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3
| 510(k) #: | K230644 | 510(k) Summary | Prepared on: | 2023-02-24 |
|---|---|---|---|---|
| ----------- | --------- | ---------------- | -------------- | ------------ |
Contact Details
| Applicant Name | Kulzer, LLC | 21 CFR 807.92(a)(1) |
|---|---|---|
| Applicant Address | 4315 S. Lafayette Blvd South Bend IN 46614 United States | |
| Applicant Contact Telephone | (574) 299-5421 | |
| Applicant Contact | Mr. David Vincent | |
| Applicant Contact Email | David.Vincent@kulzer-dental.com |
Device Name
| Device Trade Name | Signum opaque F | 21 CFR 807.92(a)(2) |
|---|---|---|
| Common Name | Tooth shade resin material | |
| Classification Name | Material, Tooth Shade, Resin | |
| Regulation Number | 872.3690 | |
| Product Code | EBF |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | 21 CFR 807.92(a)(3) |
|---|---|---|---|
| K152373 | VITA VM LC FLOW | EBF |
Device Description Summary
21 CFR 807.92(a)(4)Signum opaque F is a light-curing, one component opaquer used for extraoral color-masking of framework structures for crowns, bridges, and/or partial dentures. The veneering composites are processed by dental restoration by veneering framework-supported restorations, such as metal or zirconia frameworks.
Signum opaque F is a paste stored in a syringe featuring a plunger and a closing cap. The product is dispensed and is then applied with a disposable brush until the scaffolding frame is completely covered. After polymerization, the crown or bridge is inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
Intended Use/Indications for Use
Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.
Indications for Use Comparison
Our submission device, Signum opaque F and the predicate device, VITA VM LC Flow (K152373) have the same indications for use. They both are used in conjunction with bonding systems and provide a layer of resin type material to act as an opaquer is to mask framework structures. They both have the indication for extraoral use with veneering materials. VITA VM LC Flow (K152373) also has individualization of acrylic teeth, long term temporaries, and reproduction of gingival areas. While the verbiage of the indications for use differs and the scope of the indications for use of they are both indicated for extraoral use and have the indication to act as an opague laver to mask the underlying metal frameworks.
4
Our indication for use for Signum opaque F is listed as one of the indications listed for the predicate device, VITA VM LC Flow (K152373), They are both used as an opaquer for color-masking of framework structures.
Technological Comparison
21 CFR 807.92(a)(6)
Signum opaque F and the predicate device, VITA VM LC Flow (K152373) are dispensed in a paste form. Signum opaque F's primary packaging is a 3ml syringe with plunger and closing tip is used for dispensing of the product. Signum opaque F is placed on the mixing block and stired thoroughly. The opaque is applied with a suitable, disposable brush in several, uniform, semioverlapping layers until the scaffolding frame is completely covered. Each layer must be polymerized individually. Vita VM LC Flow is also packaged in a syringe with a plunger to extruded, Vita VM LC recommends using a metal spatula to adjust thixotropically (their consistency can be changed - from firmer to softer - by slightly pressing onto them with an instrument). VITA VM LC Flow is then applied in layers and polymerized.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Mechanical testing was performed in regard to testing shear bond strength. This testing was performed on various metal frameworks (i.e. non-precious metal, precious metal, zirconium dioxide, PEEK (high performance polymers)).
Thermal testing was performed in the shelf-life report, utilizing testing methods at differing temperatures.
All nonclinical testing was performed with conformity to applicable standards.
This clinical evaluation is based on internal data and scientific literature currently available about veneering composites and comparable medical devices. Veneering composites of Kulzer are marketed purpose without any hithout any hint for negative benefit-risk ratio. The final individualized medical devices, prepared in a conventional process, is well-established. Therefore, clinical investigation with veneering composites c&b is not necessary and the route for this clinical evaluation is literature based.
In regard to the conforming standards of both Signum opaque F and the predicate device VITA VM LC Flow, the same standards are referenced. Therefore, it can be determined that the testing methods and results of both devices are in alignment and substantial equivalence can be concluded.