(126 days)
Not Found
Not Found
No
The device description and intended use clearly define the device as a dental impression material, which is a physical substance, not a software or system that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a dental impression material used for diagnostic and planning purposes, not for treating a disease or condition.
No
The device description indicates it is a dental impression material used for creating molds, which is a manufacturing or procedural tool, not for diagnosing conditions.
No
The device description clearly states it is a "dental impression material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental impressions for various dental procedures (crown and bridge, edentulous, orthodontic, implant). This is a physical process of capturing the shape of oral structures.
- Device Description: The device is a material used to create these impressions. It's a physical substance, not something that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on biological markers.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This dental impression material does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ELW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Kerr Corporation, Kerr VPS Impression Material
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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.
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
1
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.
2
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
3
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)
1
Kei Muller for MSR
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091613