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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a dental device called "Signum opaque F." However, it does not contain information about the acceptance criteria or the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a traditional 510(k) submission for a non-AI dental material (tooth shade resin material). It focuses on:

Substantial Equivalence: Comparing the new device (Signum opaque F) to a legally marketed predicate device (VITA VM LC FLOW) in terms of indications for use, technological characteristics, and conformance to standards.
Mechanical and Thermal Testing: Mentioning that these tests were performed (shear bond strength, shelf-life at differing temperatures) but without providing specific acceptance criteria or detailed results.
No Clinical Study for Performance: Stating that a clinical investigation "is not necessary and the route for this clinical evaluation is literature based" because the product type (veneering composites) is "well-established."

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, test sets, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided text.

The request's parameters (AI/ML context, ground truth, experts, MRMC, etc.) are generally relevant to submissions for AI/ML-enabled medical devices, which leverage algorithms that interpret or process medical data. The provided document concerns a dental material's physical and chemical properties and its intended use, not an AI's diagnostic or predictive performance.

Summary

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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)

K230644

Device Name

Signum opaque F

Indications for Use (Describe)

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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510(k) #:	K230644	510(k) Summary	Prepared on:	2023-02-24
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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.

21 CFR 807.92(a)(5)

Intended Use/Indications for Use

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.

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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.

Regulation Number and Section

§ 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.