Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.

Device Description

Dentsoll High Dental Denture Resins are acrylic and polyamide resins for use in creating, relining, repairing, and rebasing denture bases. They are available in clear or pink colors. The Rezen NF and Acrytone resin granules can be used for injection molding and the ISO FAST self curing resin is mixed and applied as a liquid for repairs.

AI/ML Overview

The provided text describes the acceptance criteria and the study for "Dentsoll - High Dental Denture Resins." However, it focuses on non-clinical performance and biocompatibility testing, not on clinical studies with human readers or AI algorithms. As such, many of the requested fields are not applicable to the information given.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Physical Properties	ISO 20795-1 Denture Base Polymers	Passed all tests in accordance with ISO 20795-1
Physical appearance	ISO 20795-1	Passed
Surface property	ISO 20795-1	Passed
Hue stability	ISO 20795-1	Passed
Transparency	ISO 20795-1	Passed
Presence of air bubbles	ISO 20795-1	Passed
Flexural strength	ISO 20795-1	Passed
Flexural elasticity	ISO 20795-1	Passed
Bonding strength	ISO 20795-1	Passed
Presence of residuals	ISO 20795-1	Passed
Water sorption	ISO 20795-1	Passed
Solubility	ISO 20795-1	Passed
Biocompatibility	ISO 10993	Passed all tests in accordance with ISO 10993
Cytotoxicity	ISO 10993-5 (Pass/Fail)	Pass
Sensitization	ISO 10993-10 (Pass/Fail)	Pass
Systemic Toxicity	ISO 10993-11 (Pass/Fail)	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for individual tests, but the device undergoes general "device testing" and "biocompatibility analysis." The standards (ISO 20795-1, ISO 10993) would define the specific sample sizes required for each test.
Data Provenance: Not explicitly stated, but implies laboratory testing performed by Dentsoll, Inc. (or a contracted lab) in accordance with international standards. There is no mention of country of origin of the data or if it's retrospective or prospective in the clinical study sense. It's non-clinical, laboratory data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This information is relevant for clinical studies involving expert interpretation, typically in diagnostic imaging or similar fields. The provided document describes non-clinical, laboratory-based performance and biocompatibility testing against defined international standards. Ground truth is established by objective measurements against these standards, not by expert consensus in the human interpretation sense.

4. Adjudication method for the test set:

Not applicable. This concept applies to clinical studies where human readers might disagree, requiring a method to reach a consensus ground truth. For non-clinical tests, results are typically objective measurements against a standard.

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 device is a dental resin, not an AI software or a diagnostic tool that would involve human readers or AI assistance in interpretation.

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

Not applicable. This device is a material, not an algorithm.

7. The type of ground truth used:

Non-clinical Standard Compliance: The ground truth for performance testing is established by the specified international standards: ISO 20795-1 for physical properties and ISO 10993 for biocompatibility. The "ground truth" is that the material meets the quantitative and qualitative requirements set forth in these standards.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning model. The device is a manufactured material.

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

Not applicable. As above, there is no training set mentioned or relevant for this type of device.

Summary

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Appendix 1 JUL 2 6 2013

510(k) Summary

K130680 510(k) Summary Pursuant to 21 CFR 807.92

General Company Information

Company Name:	Dentsoll, Inc.
Company Address:	5836 Buford Hwy. #A,Norcross, GA 30071

Company Telephone:

Contact:

Contact Address:

770-314-5226

May 8, 2013

David C. Furr, MS FDC Services, LLC

8708 Capehart Cove Austin, Texas 78733 (512) 906-9654

Date:

Device Trade Names:

Classification Name and Reference:

Predicate Devices:

ACRYTONE, REZEN NF, and

ISO FAST denture resins

Resin, Denture, Relining, Repairing, Rebasing Product Code EBI 21 CFR§872.3760

PalaXpress ultra Heraeus Kulzer, LLC K110037, Cleared 04/29/2011

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DEFLEX NUXEN S.R.L. K113608, Cleared 04/10/2012

Intended Use:

Device Description:

Performance Data:

(Nonclinical and/or Clinical): The results of non-clinical testing demonstrated that the devices are safe and effective. Device testing of the Dentsoll High Dental Denture Resins was conducted in accordance with ISO ISO 20795-1 Denture Base Polymers. Testing included physical appearance, surface property, hue stability, transparency, presence of air bubbles, flexural strength, flexural elasticity, bonding strength with a dental implant, presence of residuals, water sorption, and solubility.

Biocompatibility:

Dentsoll High Dental Denture Resins are formed into surface contacting dental

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devices with limited (less than 24 hours) contact duration. Biocompatibility of the resins was analyzed in accordance with ISO 10993. Testing included the following:

ISO 10993-5 Cytotoxicity - pass ISO 10993-10 Sensitization - pass ISO 10993-11 Systemic Toxicity - pass

There are no significant differences between the Dentsoll High Dental Denture Resins and the predicate devices. All devices are tested to meet ISO 20795 and ISO 10993. Formulations, presentation, and colors are very similar. The devices are substantially equivalent.

Conclusion:

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Image /page/3/Picture/12 description: The image shows the logo of the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the graphic, there is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

July 26, 2013

Dentsoll, Incorporated C/O Mr. David C. Furr, MS FDC Services, Limited Liability Company 8708 Capehart Cove . Austin, Texas 78733

Re: K130680

Trade/Device Name: Dentsoll - High Dental Denture Resins Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: 11 Product Code: EBI Dated: March 12, 2013 Received: May 14, 2013

Dear Mr. Furr:

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 - Mr. Furr

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/Safety/ReportalProblem/dcfault.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,

Mary S. Runner -S

Kwame Ulmer. M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Dentso!! - High Dental Denture Resins

Indications for Use Statement

130680

510(k) Number:

Device Name: Dentsoll - High Dental Denture Resins

Indications For Use:

Prescription Use X (per CFR 801.109)

Over-the-counter use

Concurrence of CDRH

Sheena A. Greet 2013.07.26 11 138 00 000

for M. Susan Runner, DDS, MA

(Division Sign-Off) Islon of Anesthestology, General Hospital Infection Control, Dental Device 510(k) Number:

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.