Toke 1 Advonced is a complete system of vinylpolysiloxane impression materials composed of addition silicone chemistry where reaction between vinyl-terminated polydimethyl siloxane and poly-hydrogen siloxane catalyzed by platinum complex catalyst generates an optimum elastomeric material suitable for all crown and bridge, edentulous and implant impressions. The Take 1 Advanced system of materials is available in five viscosities, four delivery options, and in a range of set times. Take 1 Advanced has high elongation for easy mouth removal while its elastic recovery and tear strength provide accurate, detailed impressions time after time. The Wash viscosities are available in both Cartridge and Unidose syringe, a single use delivery system. The Tray viscosity is available in both Cartridge and Volume 5:1 delivery, for use in automated dynamic mixing machines. Take 1 Advonced offers three setting speeds: Regular Set, Fast Set, and Super Fast Set. Take 1 Advanced Putty is also available for Putty/Wash technique.

AI/ML Overview

The provided text describes a 510(k) submission for a dental impression material named "Take 1 Advanced." This submission focuses on demonstrating substantial equivalence to a predicate device ("Take 1") based on non-clinical performance data (biocompatibility and bench testing) rather than clinical testing or an AI algorithm. Therefore, many of the requested elements for an AI-based device, such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, are not applicable.

However, I can extract the acceptance criteria related to the device's technical characteristics and summarize the reported performance based on the non-clinical data.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating comparable performance to the predicate device, "Take 1 (K091613)", across various physical and chemical properties. The study concluded that "Take 1 Advanced" is substantially equivalent to the predicate device based on these comparisons.

Acceptance Criteria (Comparison to Predicate Device "Take 1")	Reported Device Performance ("Take 1 Advanced")
Biocompatibility: Safe for intended use	Demonstrated safe through: Agar Diffusion Test- ISO Direct Contact, ISO Kligman Maximization Test, and ISO Oral Irritation Test.
Method of Manipulation: Comparable to predicate	Evaluated and found comparable to predicate.
Work Time: Comparable to predicate	Evaluated and found comparable to predicate.
Set Time: Comparable to predicate	Evaluated and found comparable to predicate.
Strain in Compression: Comparable to predicate	Evaluated and found comparable to predicate.
Deformation Recovery: Comparable to predicate	Evaluated and found comparable to predicate.
Mixed Paste Consistency: Comparable to predicate	Evaluated and found comparable to predicate.
Dimensional change: Comparable to predicate	Evaluated and found comparable to predicate.
Hardness (Shore A): Comparable to predicate	Evaluated and found comparable to predicate.
Compatibility with Die/Cast Material: Comparable to predicate	Evaluated and found comparable to predicate.
Tensile Strength: Comparable to predicate	Evaluated and found comparable to predicate.
Tensile Elongation: Comparable to predicate	Evaluated and found comparable to predicate.
Tear Strength: Comparable to predicate	Evaluated and found comparable to predicate.
Contact Angle: Comparable to predicate	Evaluated and found comparable to predicate.

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

The document does not specify a "test set" in the context of an AI device. The testing conducted was non-clinical (biocompatibility and bench testing) to compare "Take 1 Advanced" against a predicate device. The sample sizes for these specific bench tests are not provided in the summary, nor is the country of origin explicitly stated, though the submitting company is based in Orange, California, USA. The data is retrospective in the sense that it relies on existing established test methods and comparisons to an already-marketed device.

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

Not applicable. There was no "ground truth" to establish in the context of an AI device's performance. The evaluation was based on objective, quantifiable physical and chemical properties measured, and biocompatibility testing.

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

Not applicable. No clinical or human-reader-based adjudication was involved.

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 device, and no MRMC study was conducted.

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

Not applicable. This is a dental impression material, not an algorithm.

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

The ground truth was established through objective measurements of physical and chemical properties (e.g., work time, set time, strain in compression, hardness) and standardized biocompatibility tests as per ISO guidelines (Agar Diffusion Test, Kligman Maximization Test, Oral Irritation Test). The "truth" was whether these measurements for "Take 1 Advanced" were comparable to those of the predicate device, "Take 1."

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary

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130869

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The word 'Submitter' is written below 'SYBRON DENTAL SPECIALTIES'.

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

March 2013 Date Summary Prepared:

Trade name Take 1 Advanced .
Common name Dental Impression Material .
Classification name Impression Material, per 21 CFR 872.3660 .
Product Code ELW o

510(k) Summary

Devices for Which Substantial Equivalence is Claimed:

Take 1, Kerr Corporation, K091613 o

Device Description

Indications for Use

Take 1 Advanced is a complete system of vinylpolysiloxane impression materials suitable for all crown and bridge, edentulous and implant impressions.

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MAY 3 0 2013

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Summary of Technological Characteristics ·

で

DescriptiveInformation	Take 1 Advanced	Take 1K091613
Company	Kerr Corporation	Kerr Corporation
Indications for Use	Take 1 Advanced is a completesystem of vinylpolysiloxaneimpression materials suitable forall crown and bridge, edentulousand implant impressions.	Take 1 is an addition-cure vinlypolysiloxane dental impressionmaterial that is used for allcrown and bridge, edentulous,orthodontic and implantimpression techniques.
Description ofMaterial	Vinly Polysiloxane	Vinly Polysiloxane
Mode of Use	1. Take 1 Advanced Lightbody/Regular body wash:A very hydrophilic impressionmaterial used in heavy/wash orputty/wash impressionprocedures and capable ofcapturing extraordinarysubgingival details. It is used incrown and bridge and all highprecision applications.2. Take 1 Advanced Medium body:A medium viscosity monophaseimpression material withsuperior mechanical strengthused in single step impressionprocedures such as mouthguards, night guards,orthodontic, and edentulousapplications.3. Take 1 Advanced Tray:A heavy body impressionmaterial combining strength,elasticity and dimensionalstability to deliver the mostaccurate impressions. It is usedin two-step heavy-washapplications such as for crownand bridge procedures.	1. Take 1 Light body/Regularbody wash:A very hydrophilic impressionmaterial used in heavy/washor putty/wash impressionprocedures and capable ofcapturing extraordinarysubgingival details. It is usedin crown and bridge and allhigh precision applications.2. Take 1 Medium body:A medium viscositymonophase impressionmaterial with superiormechanical strength used insingle step impressionprocedures such as mouthguards, night guards,orthodontic, and edentulousapplications.3. Take 1 Tray:A heavy body impressionmaterial combining strength,elasticity and dimensionalstability to deliver the mostaccurate impressions. It isused in two-step heavy-washapplications such as for crownand bridge procedures.
DescriptiveInformation	Take 1 Advanced	Take 1K091613
Principles ofOperation	Take 1 Advanced is a dentalimpression that takes imprints ofhard (teeth) and/or soft tissues.Take 1 Advanced captures a partor all of a person's dentition andsurrounding structures of oralcavity. The dental impressionforms an imprint (i.e. a 'negative'mold) of teeth and soft tissues,which can then be used to makea cast of the dentition. Animpression is made by placing aviscous, thixotropic impressionmaterial into the mouth via adental impression tray. Thematerial, then sets to become anelastic solid, and, when removedfrom the mouth, provides adetailed and stable negative ofteeth.	Take 1 is a dental impressionthat takes imprints of hard(teeth) and/or soft tissues. Take 1captures a part or all of aperson's dentition andsurrounding structures of oralcavity. The dental impressionforms an imprint (i.e. a 'negative'mold) of teeth and soft tissues,which can then be used to makea cast of the dentition. Animpression is made by placing aviscous, thixotropic impressionmaterial into the mouth via adental impression tray. Thematerial, then sets to become anelastic solid, and, when removedfrom the mouth, provides adetailed and stable negative ofteeth.
Shelf-Life	3 years	3 years

)

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Non-Clinical Performance Data

Biocompatibility studies were completed which demonstrate that the material is safe for its intended use. Take 1 Advanced was tested through the following tests: Agar Diffusion Test- ISO Direct Contact, ISO Kligman Maximization Test and ISO Oral Irritation Test.

The 510(k) submission also includes data from bench testing used to evaluate performance characteristics of Take 1 Advanced as compared to the predicate device, Take 1 currently marketed by Kerr Corporation. The characteristics evaluated include Method of Manipulation, Work Time, Set Time, Strain in Compression, Deformation Recovery, Mixed Paste Consistency, Dimensional change, Hardness (Shore A), Compatibility with Die/Cast Material, Tensile Strength, Tensile Elongation, Tear Strength and Contact Angle.

Clinical Testing

Clinical testing has not been conducted on this product.

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Conclusion

: 1 .

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

May 30, 2013

Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K130869

Trade/Device Name: Take 1 Advanced Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 28, 2013 Received: April 01, 2013

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-(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 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely yours, 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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SECTION 4

Indications for Use Statement

Kerr Corporation - Take 1 Advanced - 510(k) Submission

Section 004 - Page 1 of 2 ·

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43,8669 510(k) Number (if known):

Device Name: Take 1 Advanced

Indications For Use:

Take 1 Advanced is a complete system of vinylpolysiloxane impression materials suitable for all crown and bridge, edentulous and implant impressions.

Prescription Use_ × (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)

Susan Runner, DDS, MA

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K130869
----------------	---------

Kerr Corporation - Take 1 Advanced - 510(k) Submission

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).