Take 1 Advanced Rigid Tray is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Device Description

The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and implant impression techniques. Take 1 Advanced Rigid Tray is a two-part, base/catalyst – paste/paste system. The product is available in a heavy body viscosity, offered in cartridge 1:1 delivery and Volume 5:1 delivery, and in 3 setting speeds: regular set, fast set and super fast set.

AI/ML Overview

The provided text describes a 510(k) submission for a dental impression material, Take 1 Advanced Rigid Tray. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in the way an AI/ML device study would. Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods is not directly applicable or available in the provided text for a device like this.

However, I can extract the information that is present and indicate where it's not applicable.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are implied by demonstrating substantial equivalence to its predicate for certain material properties, rather than explicit numerical thresholds the device must achieve independently. The reported performance is comparative.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Performance characteristics of Take 1 Advanced Rigid Tray are comparable to the predicate device (Take 1 Advanced Rigid Tray, K092176).	Evaluated characteristics included, but were not limited to: Working Time, Setting Time, Compressive Strength, Diametral Strength, Flexural Strength, and Shore D Hardness. The submission implies these were found to be comparable to the predicate, leading to a substantial equivalence conclusion.
Device is safe for its intended use (biocompatibility).	A biocompatibility study according to ISO 10993 was completed, demonstrating the device is safe for its intended use.

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

Sample Size: Not explicitly stated for specific tests (e.g., how many samples for compressive strength were tested). The text mentions "data from bench testing," implying multiple tests were performed.
Data Provenance: Bench testing data. No geographic origin is specified, but it was performed by Sybron Dental Specialties, Inc. (USA-based company). Retrospective.

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

Not Applicable. This is a dental impression material. The "ground truth" for its performance is derived from physical and chemical measurements rather than expert human interpretation.

4. Adjudication method for the test set

Not Applicable. As per point 3, no human adjudication was involved in establishing performance metrics for this material.

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

No. This is not an AI/ML device, nor does it involve human readers. Clinical testing was explicitly stated as not conducted.

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

Not Applicable. This is a physical dental material; there's no algorithm.

7. The type of ground truth used

For physical/chemical properties (Working Time, Setting Time, Compressive Strength, etc.): Objective physical and chemical measurements governed by established testing standards (e.g., those specified in ISO standards for dental materials, though specific standard numbers for each test are not listed other than ISO 10993 for biocompatibility).
For biocompatibility: Adherence to ISO 10993 standards for biological evaluation of medical devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device; there is no training set in the machine learning sense. The "training" in manufacturing would relate to process control and quality assurance, not data-driven model training.

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

Not Applicable. See point 8.

Summary

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10092

APR - 8 2011

Section III - 510(k) Summary

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: April 2011

Device Name:

Trade Name Take 1 Advanced Rigid Tray ●
. Common Name - Dental Impression Material
. Classification Name - Impression Material, per 21 CFR § 872.3660

Devices for Which Substantial Equivalence is Claimed:

. Kerr Corporation, Take 1 Advanced Rigid Tray, K092176

Device Description:

Intended Use of the Device:

Take 1 Advanced Rigid Tray is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

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Summary of Technological Characteristics:

There has been no change made to design, composition, or intended use of Take 1 Advanced Rigid Tray as compared to its predicate. Additionally, Take 1 Advanced Rigid Tray has the same technological characteristics as its predicate. The only change being proposed is adding two new warnings to the Directions For Use. The new warnings state that Take 1 Advanced Rigid Tray is not recommended for use with impression trays spanning a full arch, and Take 1 Advanced Rigid Tray is not recommended for use in clinical situations where the opposing arch is a fixed partial denture.

Non-Clinical Test Data:

This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of Take 1 Advanced Rigid Trav compared to the predicate device, Take 1 Advanced Rigid Tray, K092176. The characteristics evaluated included, but were not limited to Working Time, Setting Time, Compressive Strength, Diametral Strength, Flexural Strength and Shore D Hardness.

A biocompatibility study {toxicity} has been completed according to ISO 10993, which demonstrates that Take 1 Advanced Rigid Tray is safe for its intended use.

Clinical Testing:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the biocompatibility test and the bench testing, the clinical performance of Take 1 Advanced Rigid Tray is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

Kerr Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties 1717 West Collins Avenue Orange, California 92867

APR - 8 2011

Re: K110092

Trade/Device Name: Take I Advanced Rigid Tray Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: January 10, 2011 Received: January 12, 2011

Dear Ms. Garman:

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. Garman

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/CDRHOtfices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Anthony 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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Section I -- Indications for Use

510(k) Labeling Change Being Effected Sybron Dental Specialties, Inc.

Indications for Use

510(k) Number (if known): |/ | 009 乙

Device Name: Take 1 Advanced Rigid Tray

Indications For Use:

Take 1 Advanced Rigid Tray is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suno Panes

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Dovicas
510(k) Number: K110692

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).