VENUS PEARL PLT REFILL A1 by HERAEUS KULZER, LLC

Direct restoration of Class I V cavities (acc. to G.V. Black) .
. Direct composite veneers
Shape corrections of teeth (i.e. diastemas, congenital defects in teeth etc.) .
Splinting of teeth loosened by trauma or periodontal disease .
. Indirect restorations (inlays, veneers)
Restoration of primary teeth .
Core build-up .
Repairs of porcelain, composite (in combination with an adequate repair . system)

Device Description

Venus Pearl is a, universal light-curing, radio-opaque nano-hybrid composite for antenor and posterior use. Due to the excellent material properties, a beautiful aesthetic result and a durable, high lustre polish is easily reached. Nano hybrid composite contain a blend of small particle fillers and large particle fillers that create durable and aesthetic restorations. The nano fillers panide micro that croate darable of the filler content and provide the natural aesthetic appearance. It is used as a base in Class I -- V restorations and can be placed in increments it is used as a base in Glass in Glass in othersal shades and special shades, 3 mm for the core-build-up shade and 1 mm for opaque-shades. Venus Pearl is used following the application of a dentin/enamel addlesive (e.g. Venus Fear is used lollowing the upper for use with light cured composite restorations. Venus Pearl is based on 2-Propenoic acid, (octahydro-4,7-methano-1Hindenes / Carrie bleneiminocarbonyloxy-2- , 1-ethanediy()ester (TCD-Dlindene-5-dify)blo(methyl-4,13-dioxo-3,14-dioxe-5,12-diazahexadecane-1,16diy-dimethacrylate (UDMA) (approximately 59% filler by volume, with 58% anorganic filler by volume, Banum aluminium Fluoride glass, pre-polymerized filler and highly discrete nanoparticles . The filler particle size is between 5 nm and 5 um

AI/ML Overview

This document describes the 510(k) submission for the dental restorative material "Venus Pearl." Since this is a submission for a restorative material and not a medical device with an algorithm or AI component, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details for AI) are not applicable.

The acceptance criteria here refer to the product's compliance with established standards for dental materials. The study proving this compliance is primarily based on non-clinical testing and comparison to an equivalent predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from ISO 4049:2009 for Dental Restorative Materials)	Reported Device Performance (Venus Pearl)
Physical Properties	Compliance with EN ISO 4049 requirements for restorative materials (Type 1, Class 2, Group 1)	"The physical properties of Venus Pearl were determined in accordance with the international standard EN ISO 4049. The physical properties comply with and exceed the requirements of this standard." (Section 4 & 5)
Depth of Cure	Defined by international standard EN ISO 4049	"The sensitivity to ambient light and depth of cure of Venus Pearl are slightly better than Venus Diamond and much higher than defined by the international standard." (Section 6)
Sensitivity to Ambient Light	N/A (implied by depth of cure standards)	"The sensitivity to ambient light and depth of cure of Venus Pearl are slightly better than Venus Diamond and much higher than defined by the international standard." (Section 6)
Biocompatibility	Compliance with EN ISO 10993-1:1993 for dental devices	"The biological compatibility of Venus Pearl was investigated to evaluate the toxicological risk...A biological evaluation report has confirmed that the product toxicological risk complies with ISO 10993 standard. The results were discussed in the biological evaluation report and the benefit/risk relation has been judged as positive." (Section 7 & 9)
Shelf Life/Storage Stability	Compliance with ISO 4049:2009 recommendations	"Based on the evaluation of the storage stability test the shelf life of Venus Pearl according to the recommendation of the manufacturer is 4 years when stored according with the requirements of ISO 4049: 2009." (Section 4)
Risk Assessment/Safety	Compliance with EN ISO 14971 (Risk Management for Medical Devices)	"The risk analysis according ISO 14971 was carried out for Venus Pearl and showed the application of the product according to the manufacturer's instruction for use is considered as safe." (Section 9)
Clinical Effectiveness/Performance	Evaluated against MEDDEV 2.7.1 and existing knowledge of restorative materials	"Based on the results of the clinical evaluation report 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." (Section 9)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document is for a dental restorative material, not an AI or algorithm-based device that would typically have a "test set" in the context of data analysis. The testing for Venus Pearl involved in-vitro physical property tests and biocompatibility tests, not data sets in the traditional sense for algorithm evaluation. The document does not specify the number of material samples used for these tests. Data provenance is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As above, a "test set" in the computational context does not apply here. Ground truth for material properties is established through standardized laboratory testing protocols, not expert consensus on images or diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No adjudication method is described, as there is no diagnostic test set requiring expert review.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted device, so no MRMC study or AI-related effectiveness metrics are relevant.

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

Not Applicable. This is not an algorithm-only or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of Venus Pearl is based on:
- Standardized Physical Property Measurements: Adherence to defined thresholds and methodologies outlined in international standards like EN ISO 4049.
- Biocompatibility Testing: Results from established in-vitro and in-vivo toxicology tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 standards.
- Clinical Evaluation: A literature review and risk assessment process (MEDDEV 2.7.1, EN ISO 14971) comparing the new device's characteristics and intended use to known performance and safety data of similar, well-established restorative materials (like the predicate device, Venus Diamond). This is effectively a "retrospective" clinical evaluation drawing on existing knowledge and safety profiles of the material class, rather than new prospective clinical trials for this specific submission for a similar device.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML product.

9. How the ground truth for the training set was established

Not Applicable. No training set exists.

Summary

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DEC 1 4 2011

Heraeus

Image /page/0/Picture/1 description: The image shows a handwritten number, which appears to be "112501". The numbers are written in a cursive style, with some of the digits connected. The handwriting is somewhat uneven, but the numbers are still legible.

510 (k) Summary of safety and effectiveness of the Restorative material "Venus Pead"

(1) Submitter name

Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614

Contact person: Chris Holden Tel. +1 (574) 299 - 5400

Date summary prepared: October, 28, 2011

(2) Name of the device:

Trade name: "Venus Pearl" Classification name: Tooth shade material (872.3690) Product Class: Il code EBF

(3) Substantially equivalence

Venus Pearl (Project Name SOCO - D 933) is an advanced version of the vonas Pour (s roject nd formally NEUN (K073554). The components and their ratio in Venus Diamond and Venus Pearl are similar.

The new composite was optimized for anterior restorations appropriate to the The hew composite that the intended use of Venus Pearl is identical to the approved dental composite Venus Diamond.

the approved is substantially equivalent to the product Filtek Supreme Ultra (K083610).

(4) Description of the device

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Seite 2

It is used as a base in Class I -- V restorations and can be placed in increments it is used as a base in Glass in Glass in othersal shades and special shades, 3 mm for the core-build-up shade and 1 mm for opaque-shades.

Venus Pearl is used following the application of a dentin/enamel addlesive (e.g. Venus Fear is used lollowing the upper for use with light cured composite restorations.

Venus Pearl is based on 2-Propenoic acid, (octahydro-4,7-methano-1Hindenes / Carrie bleneiminocarbonyloxy-2- , 1-ethanediy()ester (TCD-Dlindene-5-dify)blo(methyl-4,13-dioxo-3,14-dioxe-5,12-diazahexadecane-1,16diy-dimethacrylate (UDMA) (approximately 59% filler by volume, with 58% anorganic filler by volume, Banum aluminium Fluoride glass, pre-polymerized filler and highly discrete nanoparticles . The filler particle size is between 5 nm and 5 um

Based on the evaluation of the storage stability test the shelf life of Venus Based on the over according to the recommendation of the manufacturer is r con when blorde according with the requirements of ISO 4049: 2009.

(5) Intended use

Venus Pearl is a composite for anterior and posterior use

The indication of "Venus Pearl" is as follows:

Direct restoration of Class I V cavities (acc. to G.V. Black) .
Direct composite veneers .
Shape corrections of teeth (i.e. diastemas, congenital defects in teeth . etc.)
Splinting of teeth loosened by trauma or periodontal disease .
Indirect restorations (inlays, veneers) .
Restoration of primary teeth 트
Core build-up 1
Repairs of porcelain, composite (in combination with an adequate repair . system)

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(6) Technical Characteristic

Venus Pearl was developed as Universal composite with a soft/creamy venus I can was corethe development of the composite product Venus Consistency based on the esse planned to be an ideal supplement in a high quality product family of universal composites.

The international standard EN ISO 4049 has defined basic properties for dental I he international other and the clinical effectiveness. The specification of Composite materiale to Shoute Venus Diamond meets the requirements of the venus i ean like the productive restorative materials of all cavities (type1, class 2, group 1).

The sensitivity to ambient light and depth of cure of Venus Pearl are slightly I he scholly to amonditional advantage especially for core-build-up, however better to provide an as very close to VENUS Diamond and much higher than defined by the international standard.

(7) Nonclinical- tests

In accordance with the Medical Device Directive 93/42/EWG and national in accordantor with the most station, any medical device must be evaluated by the legal medical device manufacturer regarding its clinical performance and the legal in the includes an evaluation of biocompatibility in accordance with EN Searcty. 1993-1. Venus Pearl is exclusively used for dental restoration and it can 100 10950 1: Vondo re is only contact with mucosa. The duration of contact of Venus Pearl is >30 days. According to this classification. (ISO 10993-1, Table 1) the following tests has been considered:

Cytotoxicity Sensitization Irritation Systemic toxicity Genotoxicity with the same results as for Venus Diamond.

On the basis of the test results, the biocompatibility of Venus Pean in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk-relation has been judged as positive report and the benefit how result the uncured test item in predisposed persons cannot be excluded as for Venus Diamond.

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Saite 4 (8) Clinical Evaluation

In accordance with the medical Device directive 93/42/EWG and national in accordance with the medical device is requested to be European medical device regionation (any nufacturer regarding its clinical evaluated by the legal modiou accurse a clinical evaluation in accordance with performance and Salety. This intended to critically evaluate the clinical benefits of MEDDEV 2.7.1., which is intended to online in the potential risks. Therefore, any clinical the medical device in compulsory risk management process according to EN
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 150 1497 1, and Chilocal lindings mast faxner 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 with the current Luropean medical controllowed the procedures outlined in the corresponding clinical evaluation report.

Venus Pearl is a Restorative material, light curing, which is generally classified venus Fearl is a Restorative Medical Device Directive 93/42/EEC. as a class if medical device under the would restorative material which has venus Pean Tepresents a won Knowntypes and clinical effectiveness. There is proven to expected porterfial.com potential risks when Venus pean no nint for unboarding to the instruction for use as with Venus Diamond. 18 applied according to the instruction for abouted results for Venus Pearl Considenting the evaluation succhining be expected to exhibit the claimed technical If is concluded that the product our be exposure its in is is hereformance in well controlled and thece ptable, when weighed against their benefits in well controlled and acceptable, when weight a sy ratio can be stated for Venus bentlish y. Therefore, a pountive applied in accordance with its intended use Pear, provided that the product upprruction for use. Nevertheless, a nisk for according to the manufacturer b more Venus Pearl in predisposed persons cannot be excluded as with Venus Diamond.

(9) Conclusion

The risk potential of Venus Pearl was proved. All properties of the product were verified successfully.

The biological compatibility of Venus Pearl was investigated to evaluate the ITTE blogical risk. A biological evaluation report has confirmed that the product toxicological nok. A blog.com o to 10993 standard. The results were discussed in the biological evaluation report and the benefit/risk relation has been judged as positive.

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Seite 5

The physical properties of Venus Pearl were determined in accordance with The physical properties comply with and exceed the requirements of this standard. This is stated in section (4).

Based on the results of the clinical evaluation report it is concluded that the Dasca on the results on the 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 ISO 14971 was carried out for Venus Pearl and showed the application of the product according to the manufacturer's instruction for use is considered as safe.

Venus Pearl meets all requirements relevant for dental restorative, light curing material in accordance with the Medical Device directive 93/42/EWG and national European medical device legislation. Based on the actual facts Venus national Edropour mo be effective and safe as the predicate Venus Diamond when used with the manufacturer´s instruction for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Cheryl Zimmerman Director, Quality Assurance & Regulatory Affairs Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614

DEC 1 4 2011

Re: K112501

Trade/Device Name: Venus Pearl Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 8, 2011 Received: November 10, 2011

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. 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony O. auxten

Anthony D. Watson, B.S., M.S., M.B.A. 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): K112501

Device Name: Venus Pearl

Indications for use:

Direct restoration of Class I V cavities (acc. to G.V. Black) .
. Direct composite veneers
Shape corrections of teeth (i.e. diastemas, congenital defects in teeth etc.) .
Splinting of teeth loosened by trauma or periodontal disease .
. Indirect restorations (inlays, veneers)
Restoration of primary teeth .
Core build-up .
Repairs of porcelain, composite (in combination with an adequate repair . system)

Prescription Use	X	AND/OR	Over-The-Counter Use
(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)

Shon Rurrer

(Division Sign-Off)
Division of Anesthesiology, General HospitalInfection Control, Dental Devices	Page 1 of 1
510(k) Number:	K112501

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.