Paladon ultra was developed as a heat curing high impact denture base resin similar to the substantially equivalent device Palaimpact. The product consists of powder in various shades (pink, pink veined, pink live, R50 ыланың жұмысыздың құрылы veined, light pink, light reddish pink, shade 200, dark pink) and liquid. 80 ml or 500 ml of liquid is supplied in brown glass bottles in an outer cardboard box, the 100 g or 1000 g powder is supplied in square HD-PE bottles in an outer cardboard box. 12000 g are available upon request. To make a denture, powder and liquid are mixed, in a ratio of 21 g : 10 m!. The material should be polymerised by heating. The material has a shelf life of five years and fully complies with the requirements of ISO 20795-1:2008 for denture base polymers with improved impact resistance.

AI/ML Overview

The provided text is a 510(k) Summary for the dental device "Paladon ultra." It details the device's substantial equivalence to a predicate device and notes its compliance with ISO 20795-1:2008 for denture base polymers. However, the document does not describe a study involving readers (human or AI), sample sizes for test sets, ground truth establishment by experts, or any MRMC comparative effectiveness study. The testing mentioned is focused on the physical and biological properties of the material itself.

Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical or reader-based evaluations that are not present.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Criteria / Property	Acceptance Standard (ISO 20795-1:2008)	Reported Device Performance (Paladon ultra)
Physical Properties	(Specific criteria from ISO 20795-1:2008 for denture base polymers with improved impact resistance)	"All properties comply with and exceed the requirements of the standard."
Shelf life	N/A	Five years
Biocompatibility	ISO 10993-1 and related tests (Cytotoxicity, Sensitization, Irritation / intracutaneous reactivity, Subacute / Subchronic toxicity, Genotoxicity)	"Meets the requirements of ISO 10993 standard," "benefit / risk relation has been judged as positive."
Clinical Performance	MEDDEV 2.7.1 guidelines	"Exhibit the expected performance and clinical effectiveness," "potential undesirable clinical effects and risks seem well controlled and acceptable."

2. Sample size used for the test set and the data provenance: Not applicable. The tests are on the material properties, not a dataset from patients or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/reader studies (e.g., disease presence) is not established in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 document describes a dental material, not an AI or imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document describes a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For physical properties: The ground truth is defined by the technical specifications and test methods outlined in ISO 20795-1:2008.
For biocompatibility: The ground truth is established through laboratory tests as required by ISO 10993-1.
For clinical performance: The ground truth is established by clinical evaluation in accordance with MEDDEV 2.7.1, assessing expected performance and safety based on existing knowledge and the properties of the material.

8. The sample size for the training set: Not applicable. This document describes a dental material, not an AI system with a training set.

9. How the ground truth for the training set was established: Not applicable.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a combination of non-clinical (laboratory) tests and a clinical evaluation, rather than a single study with a "test set" in the context of reader studies or AI performance.

Nonclinical Tests: These involved evaluating the material's physical properties according to ISO 20795-1:2008 for denture base polymers with improved impact resistance. Additionally, biocompatibility was assessed in accordance with ISO 10993-1, covering tests for cytotoxicity, sensitization, irritation/intracutaneous reactivity, subacute/subchronic toxicity, and genotoxicity. The document states that toxicological risk was evaluated, and a biological evaluation report confirmed the product meets ISO 10993 requirements.
Clinical Evaluation: This evaluation was performed in accordance with MEDDEV 2.7.1 and the Medical Device Directive 93/42/EEC. It involved a critical assessment of the clinical benefits versus potential risks of Paladon ultra. The evaluation concluded that the product exhibits the claimed clinical and technical performance and that potential undesirable clinical effects and risks are well controlled and acceptable when weighed against their benefits in dentistry.

In essence, the "study" is a comprehensive regulatory assessment involving adherence to established international standards for material properties and biological safety, coupled with a clinical risk/benefit analysis based on the device's intended use and comparison to existing well-known materials.

Summary

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SEP 2 9 2011

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Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by two instances of the Roman numeral 'I'. After that, there is the number '832'. The characters are written in a handwritten style, with varying stroke thicknesses.

Image /page/0/Picture/2 description: The image shows the word "Heraeus" in a bold, sans-serif font. The letters are black and appear to have a slightly rough or textured edge. The word is centered and takes up most of the frame.

510(k) Summary of Safety and Effectiveness of Paladon ultra

(1) Submitter's name

Heraeus Kulzer, LLC (for Heraeus Kulzer, GmbH) 300 Heraeus Way South Bend, Indiana 46614

Contact person: Cheryl V. Zimmerman Phone: + 574 299-5444

Date summary was prepared: 2011-05-05

(2) Name of Device

Trade name - Paladon ultra Classification name - Denture relining, repairing, or rebasing resin (21 CFR 872.3760 Product code EBI) Class - II

(3) Substantial equilvalence

Paladon ultra, liquid and powders, is substantially equivalent with Palaimpact, liquid and powders, 510(k) No. K043504

Main component of both liquids is methyl methacrylate, of the powders polymethyl methacrylate.

(4) Description of the device *

Paladon ultra was developed as a heat curing high impact denture base resin similar to the substantially equivalent device Palaimpact.

The product consists of powder in various shades (pink, pink veined, pink live, R50 ыланың жұмысыздың құрылы veined, light pink, light reddish pink, shade 200, dark pink) and liquid. 80 ml or 500 ml of liquid is supplied in brown glass bottles in an outer cardboard box, the 100 g or 1000 g powder is supplied in square HD-PE bottles in an outer cardboard box. 12000 g are available upon request.

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Heraeus

To make a denture, powder and liquid are mixed, in a ratio of 21 g : 10 m!. The material should be polymerised by heating.

The material has a shelf life of five years and fully complies with the requirements of ISO 20795-1:2008 for denture base polymers with improved impact resistance.

(5) Intended use

Paladon ultra is a denture base material for fixed and removable dentures:

Full maxillary and mandibular prostheses .
Implant overdenture .

(6) Summaries and Conclusion

(a) Technological Characteristics

Paladon ultra was developed as a heat-polymerizing high impact resin with improved impact resistance. In all properties it is comparable with the essentially equivalent heat-polymerizing denture base resin Palaimpact. Paladon ultra is a further development of the earlier product.

(b) Nonclinical tests and clinical tests/evaluations

(1) Nonclinical tests: In accordance with the Medical Device Directive 93/42/EEC and National European medical device legislation, any medical device, must be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with ISO 10993-1. As Paladon ultra is exclusively used for the fabrication denture bases as well as implant-supported prostheses, it can be concluded that there is only contact with the mucosa. The duration of contact of Paladon ultra is > 30 days. According to this classification, (DIN EN ISO 10993-1, Table 1) the following tests must be considered: Cytotoxicity, Sensitization, Irritation / intracutaneous reactivity, Subacute / Subchronic toxicity, Genotoxicity. On the basis of the test results, the

biocompatibility of Paladon ultra in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit / riskrelation has been judged as positive.

(2) Clinical evaluation
In accordance with the Medical Device Directive 93/24/EEC and National European medical device evaluation, any medical device is requested to be

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Heraeus

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, a clinical evaluation is part of the compulsory risk management process according to 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 critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.

Paladon ultra is classified according to annex IX of council directive 93/42/EEC as a class Ila medical device.

Paladon ultra represents as well-known type of acrylic denture base material which has proven to exhibit the expected performance and clinical effectiveness. There is no hint for undesirable effects and potential risks when Paladon ultra is applied according to the instructions for use. Considering the evaluated data and technical results for Paladon ultra, it is concluded that the product will exhibit that claimed clinical and technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against their benefits in dentistry. Therefore, the benefits versus risks ratio was stated to be positive for Paladon ultra, provided that the product is applied in accordance with its intended use according to the manufacturer's information for use. Nevertheless, a risk for irritation or sensitization in susceptible patients or users due to the contact with Paladon ultra cannot be excluded.

The clinical report was carried out in accordance with MEDDEV 2.7.1 and followed the provisions of the corresponding clinical evaluation plan.

The risk potential of the denture base resin Paladon ultra was proven. All properties.of.the product were verified.successfully ... .....................................................................................................................

The biological compatibility of the denture base resin was investigated to evaluate the toxicological risk. A biological evaluation report has confirmed that the product Paladon ultra meets the requirements of ISO 10993 standard. The results were discussed in the biological evaluation report and the benefit / risk relation has been judge as positive.

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Heraeus

The physical properties of Paladon ultra were determined in accordance with ISO 20795-1 for denture base polymers. All properties comply with and exceed the requirements of the standard. This is stated in section (4).

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. The risk analysis according to ISO 14971 was carried out for Paladon ultra and showed that the application of the product according to the manufacturer's instruction for use can be considered as safe.

Paladon ultra meets all relevant requirements for denture base resins in accordance with the Medical Device Directive 93/42/EEC and National European medical device legislation. Based on the actual facts Paladon ultra is considered to be effective and safe when used in accordance with the manufacturer's instructions for use.

Webrheim, September 26, 2011

Wehrheim, Septemb

Dr. K. Ruppert

U. Lialich

A. Keishold

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and feathers represented by curved lines.

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

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

2 9 2311

Re: K111832

Trade/Device Name: Paladon Ultra Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 24, 2011 Received: August 26, 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/Reportal/roblem/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 vours.

h for

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

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Indications for Use

510(k) Number (if known): K \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \

Device Name:

Indications for use:

Paladon ultra is a heat curing high impact denture base resin designed for injection procedure and press and pack technique for:

. maxillary and mandibular prostheses
implant over-denture .

Prescription Use Over-The-Counter Use X 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)
REBER DDS Yov Dr Siremes
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K111832

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.