The provided 510(k) summary describes a device, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, which are preformed denture teeth. This notification is for a dental device, not an AI/ML powered medical device. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size) are not applicable to this type of device submission.

The submission focuses on demonstrating substantial equivalence to predicate devices (SR Vivodent PE, SR Orthotyp PE, and Phonares II) through material composition, performance data, and indications for use.

Here's the information that can be extracted from the provided text according to your request:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (Standard)	Reported Device Performance
Artificial denture teeth performance	Meets requirements defined in ISO 22112:2005 (Artificial denture teeth)	The device has been tested and meets these requirements.
Flexural Strength	Meets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials)	The device has been tested and meets these requirements.
Water Sorption	Meets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials)	The device has been tested and meets these requirements.
Solubility	Meets requirements defined in ISO 10477:2004 (Polymer based crown & bridge materials)	The device has been tested and meets these requirements.
Ball Indentation Test	Meets requirements defined in DIN EN ISO 2039-1	The device has been tested and meets these requirements.
Biocompatibility	Meets requirements defined in ISO 10993 (Biological evaluation of medical devices)	Biocompatibility testing and evaluation was carried out according to ISO 10993. The device's composition (PMMA) is well known and accepted as biocompatible.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this type of device. The submission references compliance with international standards for material properties and performance rather than clinical test sets with specified sample sizes or data provenance. The testing would have been conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in the context of AI/ML or diagnostic devices is not relevant here. The "ground truth" for this device is its adherence to established material and performance standards.

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 is a physical dental device, not an AI-assisted diagnostic tool.

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

Not applicable.

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

The "ground truth" for this device's performance is compliance with international standards (ISO 22112:2005, ISO 10477:2004, DIN EN ISO 2039-1, ISO 10993) for material properties and physical performance.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable.

Summary

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K132984

JAN 1 4 2014

510(K) SUMMARY (revised 12.11.2013)

SR Vivodent S, SR Orthotyp S, SR Ortholingual S

Contact:	Donna Marie Hartnett, Director of QA/Regulatory Affairs
Company:	Ivoclar Vivadent. 175 Pineview Drive, Amherst, NY 14228(716) 691-0010
Date Prepared:	December 11, 2013
Proprietary Name:	SR Vivodent S, SR Orthotyp S, SR Ortholingual S
Classification Name:	Denture, Plastic, Teeth (872.3590)
Predicate Devices:	SR Vivodent PE, SR Orthotyp PE (K844349) and Phonares II (K120736)

Preformed denture teeth used for total and partial dentures and implant-Device Description: supported removable prostheses.

The predicate device to which SR Vivodent S, SR Ortholingual S have been compared is SR Vivodent PE, SR Orthotyp PE (K844349) and Phonares II (K120739) For this application, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, has been compreed to 1841349 predicate with regard to chemical composition, performance data and indications for use The subject device has also been compared to Phonares II (K120739) with regard to indications for use. The comparison shows that SR Vivodent S, SR Orthotyp S, SR Ortholingual a are substantially equivalent to the predicate devices.

Intended Use: Preformed denture teeth used for total and partial dentures and implantsupported removable prostheses.

Technological Characteristics: The device design, i.e. delivery form, and intended use of SR Vivodent S, SR Orthotyp S, SR Ortholingual S, and the predicate device are the same. The composition of the subject device has been modified from the predicate; however, there are no ingredients in the subject device which pose any new issues of safety and effectiveness i

Testing Summary: The Device has been tested in accordance with ISO 22112:2005 for Artificial denture teeth and it meets the requirements defined. The device was also tested in accordance with ISO 10477:2004 Polymer based crown & bridge materials for Flexural Strength, Water somion and Solubility. Finally, the materials were tested using a Ball Indentation test according to DIN EN ISO 2039-1. Biocompatibility testing and evaluation was also carried out according to ISO 10993. The subject device is a PMMA denture tooth, the composition of which is well known and accepted as biocompatible in dentistry.

Conclusion: SR Vivodent S, SR Orthotyp S, SR Ortholingual S, is substantially equivalent to the predicate device.

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Concurrence & Template History Page [THIS PAGE IS INCLUDED IN IMAGE COPY ONLY]

Full Submission Number:

For Office of Compliance Contact Information:

http://insideportlets.fda.gov:9010/portal/page?_nageid=197,415881&_dad=portal&_schema=PORTAL&org=318

For Office of Surveillance and Biometrics Contact Information:

http://insideportlets.fda.gov:9010/portal/page?_pageid=197,415881&_dad=portal&_schema=PORTAL&org=423

Digital Signature Concurrence Table
Reviewer Sign-Off	Myra Browne
Branch Chief Sign-Off	Susan Runner
Division Sign-Off	Kwame O=Ulmer S2014.01.14 13:36:24 -05'00'

Template Name: K1(A) – SE after 1996

Template History:

Date of Update	By	Description of Update
7/27/09	Brandi Stuart	Added Updates to Boiler Table
8/7/09	Brandi Stuart	Updated HFZ Table
1/11/10	Diane Garcia	Liability/Warranty sentence added at bottom of 1st page
10/4/11	M. McCabe Janicki	Removed IFU sheet and placed in Forms
9/25/12	Edwena Jones	Added digital signature format
12/12/12	M. McCabe Janicki	Added an extra line between letter signature block and the word"Enclosure". Also, added a missing digit in 4-digit extension onletterhead zip code: "002" should be "0002".
4/2/2013	M. McCabe Janicki	Edited sentence that starts "If you desire specific advice for yourdevice on our labeling regulation (21 CFR Part 801) " Replacedbroken Compliance link with general link to DSMICA.
4/12/2013	Margaret McCabeJanicki	Fixed a typo: Paragraph 1, final sentence, "We remind you.however; that device labeling must be truthful" Replacedincorrect semicolon with a comma.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is simple, yet recognizable, and is often used on official documents and websites related to the department.

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

January 14, 2014

Ivoclar Vivadent, Incorporated Ms. Donna Marie Hartnett Director Quality Assurance/Regulatory Affairs 175 Pineview Drive Amherst, NY 14228

Re: K132984

Trade/Device Name: SR Vivodent S, SR Orthotyp S, SR Ortholingual S Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: October 15, 2013 Received: October 16, 2013

Dear Ms. Hartnett:

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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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 (OS) 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

Sincerely yours,

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Kwame O.
Ulmer-S

for

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

510(k) Number (if known): K132984

Device Name: SR Vivodent S, SR Orthotyp S, SR Ortholingual S

Indications For Use:

Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

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

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) Page 1 of 1

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Regulation Number and Section

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.