(86 days)
No
The device description and performance studies focus on the material properties and physical performance of a dental impression material, with no mention of AI or ML.
No
The device is a dental impression material used for diagnostic and planning purposes, not for directly treating a disease or condition.
No
The device is described as a dental impression material used for taking impressions of teeth and gums, which is a manufacturing or procedural step rather than a diagnostic process. It does not analyze patient data or provide medical insights for diagnosis.
No
The device is a dental impression material, which is a physical substance, not software. The description clearly outlines its chemical composition and physical properties.
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 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 dental impression material, a physical substance used to create a mold.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The process described is purely mechanical/physical.
Therefore, this device falls under the category of a dental material used for creating physical impressions, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
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 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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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:
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.
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.
1
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.
2
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.
3
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
4
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