Direct restorations of Black classes I V. ●
Direct composite veneers .
Shape corrections of teeth .
Temporary splinting of teeth loosened by trauma or periodontal disease .
. Indirect restorations (inlays, veneers)
. Restoration of primary teeth
Core build-up .
Temporary repairs of composite and ceramics (in combination with a suitable . repair system)

Device Description

An improved light curing dental filling composite was developed within the scope of the project NEUN on the base of customary radical cross linking (meth)-acrylate monomers and dental glass fillers. The material is characterized by the following properties in detail:

The material is a light curing nano hybride composite. .
. The monomer matrix included is a particularly low-shrink mixture of polyether and urethane monomers preponderantly.
A special TCD backbone monomer makes the excellent mechanical properties and the low . shrinkage possible. (TCD = tricyclodecane)
. The composite material does not contain any Bis-GMA monomer making it toxicologically advantageous, as no Bisphenol-A can be released.
The filler contained is a mixture of various particle size fractions of a customary, radiopaque dental . alass.
The composite material contains non-agglomerated nano particles cross-linking to the polymer . network.
. The material has a pasty consistency and can be applied plastically into the cavity. It is hardly sticky, packable, can be moulded, cured by blue light and polished with common systems.
. Handling is comparable with customary light curing dental composite materials. For deeper cavities layering technique is recommended.
In its unpolymerized state, the composite material is plastically workable (pliable) similar to current products. Using a special initiator system reduced the sensitivity to ambient light. Cross-linking reaction is initiated with light curing devices (QTH, LED) customary in dental technology. Radical cross-linking of the (meth)- acrylate monomers occurs very fast, ensuring complete curing of a layer with a thickness of over 2 mm in an irradiation time of 20 seconds.
Thus, a highly cross-linked composite material results, fully complying with the mechanical requirements for a dental filling material in the Black classes I, II, III, IV and V according to the international standard EN ISO 4049.

AI/ML Overview

The provided text describes a new dental filling composite named NEUN and its evaluation for regulatory clearance. Here's a breakdown of the acceptance criteria and the study performed, based only on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for dental restorative materials.

Acceptance Criterion (Standard/Property)	Reported Device Performance (NEUN)
Biocompatibility (EN ISO 10993-1)	Verified; did not show a significant toxicological reaction. Meets requirements of DIN EN ISO 10993 standard. Positive benefit/risk-relation.
Physical Properties (EN ISO 4049)	Fully complies with mechanical requirements for dental filling material in Black classes I, II, III, IV and V. Meets requirements of the harmonized standard for dental restorative materials of all cavity classes (type 1, class 2, group 1). Shows similar or better results compared to registered and commercially available products in in-vitro tests.
Clinical Effectiveness/Safety (MEDDEV 2.7.1)	Expected to exhibit claimed technical results. Potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against benefits. Positive risks versus benefits ratio can be stated by the Expert. Application of NEUN considered safe based on risk analysis (DIN EN ISO 14971).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for any specific test set in the context of clinical or physical property evaluation. It refers to "in-vitro tests" for physical properties and "clinical studies" and a "clinical investigation report" for clinical evaluation.

Physical Properties: "All important properties were proved with in-vitro tests." No sample size is given.
Biocompatibility: "The biological compatibility... was verified in accordance with the international standard." "A certified laboratory has confirmed the prototype of NEUN meets the requirements of the DIN EN ISO 10993 standard." No specific sample size or data provenance (e.g., country of origin, retrospective/prospective) for the biocompatibility testing is provided, beyond the mention of a "laboratory prototype" and a "prototype from the production."
Clinical Evaluation: "Based on the results of the clinical studies..." No sample size or data provenance is detailed for the clinical studies mentioned. The clinical evaluation followed MEDDEV 2.7.1.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Biocompatibility: The evaluation was conducted by a "certified laboratory." The "benefit/risk-relation has to be judged as positive" and was "discussed in a Biological Evaluation Report." No specific number or qualifications of experts involved in establishing ground truth for biocompatibility were explicitly stated, beyond the implicit expertise of a certified laboratory.
Clinical Evaluation: "Therefore, a positive risks versus benefits ratio can be stated by the Expert for NEUN..." This indicates at least one "Expert" was involved in the clinical evaluation. No specific qualifications (e.g., "radiologist with 10 years of experience") are provided for this expert.

4. Adjudication Method for the Test Set

The document does not explicitly mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the evaluations (biocompatibility, physical properties, or clinical evaluation).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, the document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The evaluation focuses on the performance of NEUN against established standards and competitor materials, not on human readers' improvement with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This device is a dental composite material, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this device. The physical and clinical evaluations are about the material itself.

7. The Type of Ground Truth Used

Biocompatibility: Ground truth was established based on compliance with the DIN EN ISO 10993 standard and the toxicological assessment results from the certified laboratory.
Physical Properties: Ground truth was established by compliance with the EN ISO 4049 standard and comparison with "best competitor materials" and "registered and commercially available products" via "in-vitro tests."
Clinical Evaluation: Ground truth for clinical performance and safety was assessed through a "clinical evaluation in accordance with MEDDEV 2.7.1," which likely involved evaluating scientific data, clinical research, and technical results against established clinical benefits and potential risks, leading to an expert's conclusion on the benefit/risk ratio. This would typically be based on clinical outcomes and safety data and expert judgment.

8. The Sample Size for the Training Set

The document does not refer to a "training set" as this is a dental material, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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KO72554 -

510(K) Summary of safety and effectiveness of a new universal composite (project NEUN)

1 Description and intended use of the medical device

The material is a light curing nano hybride composite. .
. The monomer matrix included is a particularly low-shrink mixture of polyether and urethane monomers preponderantly.
A special TCD backbone monomer makes the excellent mechanical properties and the low . shrinkage possible. (TCD = tricyclodecane)
. The composite material does not contain any Bis-GMA monomer making it toxicologically advantageous, as no Bisphenol-A can be released.
The filler contained is a mixture of various particle size fractions of a customary, radiopaque dental . alass.
The composite material contains non-agglomerated nano particles cross-linking to the polymer . network.
. The material has a pasty consistency and can be applied plastically into the cavity. It is hardly sticky, packable, can be moulded, cured by blue light and polished with common systems.
. Handling is comparable with customary light curing dental composite materials. For deeper cavities layering technique is recommended.

In its unpolymerized state, the composite material is plastically workable (pliable) similar to current products. Using a special initiator system reduced the sensitivity to ambient light. Cross-linking reaction is initiated with light curing devices (QTH, LED) customary in dental technology. Radical cross-linking of the (meth-) acrylate monomers occurs very fast, ensuring complete curing of a layer with a thickness of over 2 mm in an irradiation time of 20 seconds.

Thus, a highly cross-linked composite material results, fully complying with the mechanical requirements for a dental filling material in the Black classes I, II, III, IV and V according to the international standard EN ISO 4049.

2 Indication List

. Direct restorations of Black classes I-V
. Direct composite veneers
Shape corrections of teeth .
. Temporary splinting of teeth loosened by trauma or periodontal disease
Indirect restorations (inlays, veneers) .
4 2003

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� Restoration of primary teeth
Core build-up �
. Temporary repairs of composite and ceramics (in combination with a suitable repair-system)

3 Toxicological Evaluation

The biological compatibility of the prototype NEUN was verified in accordance with the international standard. The cured composite did not show a significant toxicological reaction.

The biocompatibility of NEUN in the aforementioned indication was documented in a Biological Evaluation Report and the benefit/risk-relation has to be judged as positive.

4 Physical Properties and compliance with ISO 4049

NEUN was developed with a focus to the best competitor materials known in the dental market. A comparison with approved dental materials demonstrates the properties of NEUN is far superior properties in every detail ..

All important properties were proved with in-vitro tests and show similar or better results in comparison with registered and commercially available products.

The international standard EN ISO 4049 has defined basic properties for dental composite materials to ensure the clinical effectiveness. The specification of the new dental composite NEUN meets the requirements of the harmonized standard for dental restorative materials of all cavity classes (type 1, class 2, group 1).

5 Clinical Evaluation

In accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes a clinical evaluation in accordance with MEDDEV 2.7.1., which is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, any clinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device.

On this background, the clinical evaluation was performed in order to comply with the current European medical device legislation, in particular with MEDDEV 2.7.1. This clinical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.

NEUN is a light-curing universal composite, which is generally classified as a Class IIa medical device under the Medical Device Directive 93/42/EEC. This universal composite is intended for high-end aesthetic restorations in the anterior and posterior areas, intended for long-term application.

Considering the evaluated scientific data, clinical research and technical results for NEUN it is concluded that the product can be expected to exhibit the claimed technical results for NCDN in IC Sconnice and that potential undesirable clinical effects and risks seem well controlled and acceptable, when weighed against their benefits in dentistry. Therefore, a positive risks versus benefits ratio can be stated by the Expert for NEUN, provided

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that the product is applied in accordance with its intended use as outlined in the manufacturer's information for use.

The clinical investigation report was prepared in accordance with MEDDEV 2.7.1 and followed the provisions of the corresponding clinical evaluation plan dated 05 July 2007.

ర్ Summarized Evaluation

The risk potential of the newly developed restorative composite NEUN was proved and evaluated with a laboratory prototype and a prototype from the production. All properties of the prototype was verified successfully. The risk potential of the newly developed material NEUN was proven with the prototype from laboratory and production.

The special composition is new, however based on a well known radical crosslink reaction of (meth)acrylate monomers. The ingredients are chemically comparable to other common dental composite materials.

The biological compatibility of the restorative material was investigated to evaluate any toxicological risk. A certified laboratory has confirmed the prototype of NEUN meets the requirements of the DIN EN ISO 10993 standard. The results was discussed in a Biological Evaluation Report and the benefit/risk-relation has to be judged as positive.

Physical Properties of NEUN was determined in comparison with the most significant competitor products. The results have shown equal or better properties of NEUN to all materials investigated. The province of NEUN meets the requirements of the DIN EN ISO 4049 standard of polymer based filling materials.

Based on the results of the clinical studies it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable, when weighed against their benefits in dentistry.

The risk analysis (according to DIN EN ISO 14971) was carried out for the composition of the prototype NEUN and showed that the application of NEUN could be considered to be safe.

The prototype of NEUN meets all requirements relevant for dental in accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation. Based on the actual facts NEUN could be evaluated to be effective and safe with its intended use as outlined in the manufacturer's information for use.

Wehrheim, 28. August 2007

H. Zoch
i.V. Dr. Andreas Wundt

Dr. Andreas Uttero

Manager R&D Dental Fillings

Annegrete Wagner
i.A. Annegrete Wagner

nearete V

Regulatory Affairs

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, topped by a single wing. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2008

Ms. Cheryl V. Zimmerman Director, Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafavette Boulevard South Bend, Indiana 46614-2517

Re: K073554 Trade/Device Name: NEUN

Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Regulatory Class: II Product Code: EBF Dated: November 29, 2007 Received: December 18, 2007

Dear Ms. Zimmerman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2- Ms. Zimmerman

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Clut

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): 1073554 Device Name: NEUN Indications for Use:

Direct restorations of Black classes I V. ●
Direct composite veneers .
Shape corrections of teeth .
Temporary splinting of teeth loosened by trauma or periodontal disease .
. Indirect restorations (inlays, veneers)
. Restoration of primary teeth
Core build-up .
Temporary repairs of composite and ceramics (in combination with a suitable . repair system)

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

Susan Curry

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of _ 1

510(k) Number: K073534

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.