ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures. Meets ISO 10139-2 and is a Shors A hardness Type A material. It is a, translucent, non-flowing, long-term soft silicone based liner. Use to reline, rebase or line new or existing dentures. ComfortSoft® Soft Denture Liner provides a cushion between the denture and the mouth tissues to aid in reducing sore spots, and allows improved adaptation to tissue contours thereby aiding in a comfortable fit of the denture.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ComfortSoft® Soft Denture Liner System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility:
MEM elution	Passed
Guinea Pig Maximization Sensitization	Passed
Intracutaneous Toxicity	Passed
Systemic Toxicity	Passed
Sub-Acute Toxicity	Passed
Ames test	Passed
Chromosomal Aberration	Passed
In vivo Mouse Micronucleus Extract	Passed
Material Properties:
Meets ISO 10139-2:2009	Passed
Shore A hardness Type A material	Confirmed (stated in description)
Bond strength	At least 1 MPa

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

The document does not explicitly state the sample sizes for the individual biocompatibility tests or the ISO 10139-2 testing. It only reports that these tests were "completed and passed."

The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be pre-market bench and biological testing conducted by or for the manufacturer. No retrospective or prospective human clinical trial data is mentioned.

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

This information is not applicable. The evaluations conducted were physical and biological tests against established standards (ISO 10139-2) and biocompatibility guidelines, not subjective expert assessments of a test set. Ground truth was established by the specifications of the tests themselves.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations were objective tests against standards rather than subjective expert assessments requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on bench testing and biocompatibility.

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

This question is not applicable to a physical medical device like a denture liner. There is no algorithm involved.

7. The Type of Ground Truth Used

The ground truth used for performance validation was based on:

International Standards: ISO 10139-2:2009 for material properties.
Biocompatibility Guidelines: Established protocols for various toxicity and sensitization tests (e.g., MEM elution, Guinea Pig Maximization Sensitization).
Manufacturer Specifications: For bond strength (at least 1 MPa).

8. The Sample Size for the Training Set

This information is not applicable. There is no machine learning "training set" for this type of device.

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

This information is not applicable for the same reason as point 8.

Summary

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APR 2 9 2014

Section 5 510k Summary

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

Date Prepared: 1/16/2014

APPUCANT

Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: 502-634-5357 502-634-4512 FAX: EMAIL: jwaters@whipmix.com

2. SUBMITTER and CONTACT

John P. Waters Regulatory Compliance Officer & Official Correspondent for Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: PHONE: 502-634-5357 FAX: 502-634-4512 EMAIL: jwaters@whipmix.com DATE: 05/24/2013

3. DEVICE NAME

ComfortSoft® Soft Denture Liner System

4. COMMON OR USUAL NAME AND CLASSIFICATION

Resin, Denture, Relining, Repairing, Rebasing Regulation Number: 872.3760 Product Code: EBI Classification: Class II

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5. PREDICATE DEVICE COMPARISON

ComfortSoft Soft Denture Liner System is substantially equivalent to Luci-Sof (trubyte) made by Dentsply (K964040). The Indications For Use for both devices state they are intended as a long term soft liner for removable dentures and are Shore A type material. Both are of a silicone type material and use and initiator/bonder. Both require a 2mm minimum denture base thickness. Luci-Sof has passed biocompatibility testing, but information is not available in comparison to ComfortSoft Soft Denture Liner. ComforSoft Soft Denture Liner passed biocompatibility tests for MEM elution, Guinea Pig Maximization Sensitization, Intracutaneous Toxicity, Systemic Toxicity, Sub-Acute Toxicity, Ames test, Chromosomal Aberration, and In vivo Mouse Micronucleus Extract. ComfortSoft soft Denture liner also has a bond strength of at least 1MPa whereas Luci-Sof claims a 15.3 kN/m²,

6. DEVICE DESCRIPTION

It is a, translucent, non-flowing, long-term soft silicone based liner. Use to reline, rebase or line new or existing dentures. ComfortSoft® Soft Denture Liner provides a cushion between the denture and the mouth tissues to aid in reducing sore spots, and allows improved adaptation to tissue contours thereby aiding in a comfortable fit of the denture.

7. INDICATIONS FOR USE

. The ComfortSoft® Soft Denture Liner System is intended for use as a long-term soft liner for removable dentures

8. BENCH TESTING

Testing according to ISO 10139-2:2009 was completed and passed.

9. BIOCOMPATIBILITY

ComfortSoft Soft Denture Liner System passed the following biocompatibility tests; MEM elution, Guinea Pig Maximation Sensitization, Intracutaneous Toxicity, Systemic Toxicity, Sub-Acute Toxicity, Ames test, Chromosomal Aberration, and In vivo Mouse Micronucleus Extract

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10. CONCLUSION

ComfortSoft® Soft Denture Liner System is substantially equivalent to Luci-Sof from Dentsply in safety and effectiveness when used in accordance with the instructions for use. Both liners are silicone liners which meet ISO 10139-2, have the same indications for use and were found to be biocompatible.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 29. 2014

Whip Mix Corporation Mr. John P. Waters Regulatory Compliance Officer 361 Farmington Avenue Louisville, KY 40217

Re: K140146

Trade/Device Name: ComfortSoft@ Soft Denture Liner System Regulation Number: 21 CFR 872.3760 Regulation Name: Resin. Denture, Relining, Repairing, Rebasing Regulatory Class: II Product Code: EBI Dated: February 4, 2014 Received: February 4, 2014

Dear Mr. Waters:

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. Waters

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Acting 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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Indications for Use

K140146 510(k) Number (if known):

Indications for Use:

The ComfortSoft® Soft Denture Liner System is intended for use as a long-term soft liner for removable dentures.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2014.04.29 08:34:47 -04'00'

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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.