Take I 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 is a two-part, base/catalyst - paste/paste system. The product is available in three viscosities, Wash, Tray, and Medium.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a dental impression material named "Take 1," confirming its substantial equivalence to a legally marketed predicate device.

The document includes:

Contact information for the submitter.
Device name, common name, and classification name.
Identification of the predicate device (Kerr Corporation, Kerr VPS Impression Material).
Device description and intended use.
A statement of substantial equivalence to other legally marketed devices.
FDA's letter acknowledging the 510(k) premarket notification and confirming substantial equivalence.
Information regarding regulatory compliance and contact details for further inquiries.
An "Indications for Use" statement for the device.

There is no information regarding specific performance metrics, acceptance criteria, study methodologies, sample sizes for testing or training, expert qualifications for ground truth establishment, adjudication methods, or results of MRMC or standalone studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with the letters connected and overlapping. Above the logo is the number K091613. Below the logo, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font.

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

OCT - 7 2009

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:

September 2009

Device Name:

ತ Trade Name - Take 1
Common Name Dental Impression Material ●
Classification Name Impression Material, per 21 CFR § 872.3660 �

Devices for Which Substantial Equivalence is Claimed:

� Kerr Corporation, Kerr VPS Impression Material

Device Description:

Intended Use of the Device:

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

Substantial Equivalence:

Take 1 is substantially equivalent to other legally marketed devices in the United States. Take 1 functions in a manner similar to and is intended for the same use as Kerr VPS Impression Material that is currently manufactured by Kerr Corporation:

1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

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

OCT - 7 2009

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

Re: K091613

Trade/Device Name: Take 1 Regulation Number: 21 CFR 872.3660. Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: October 2, 2009 Received: October 5, 2009

Dear Ms. Boswell:

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.

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. Boswell

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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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KO91613

Indications for Use

510(k) Number (if known):

Device Name: Take 1

Indications For Use:

Take I 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

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Kei Muller for MSR

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091613

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).