(191 days)
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.
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and 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.
This submission pertains to a dental impression material, which is a low-risk device. As a result, the provided documentation focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the context of AI/software. There is no mention of a study involving artificial intelligence, human readers, or specific quantitative performance metrics beyond the general characteristics expected of dental impression materials.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable to the provided information.
However, based on the context of a 510(k) submission for a non-AI device, we can infer some general "acceptance criteria" through the lens of substantial equivalence and device characteristics for dental impression materials.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI device, the "acceptance criteria" are implicitly derived from the characteristics of the predicate device and the general intended use of dental impression materials. Performance is reported through the substantial equivalence claim.
| Acceptance Criteria (Inferred from Predicate/General Device Type) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Material Type: Addition-cure vinyl polysiloxane | Addition-cure vinyl polysiloxane |
| Usage: All crown and bridge, edentulous, orthodontic, and implant impression techniques | Used for all crown and bridge, edentulous, orthodontic, and implant impression techniques |
| Viscosity: Heavy body | Heavy body |
| Delivery System: Cartridge 1:1 and Volume 5:1 | Cartridge 1:1 delivery and Volume 5:1 delivery |
| Setting Speeds: Regular, Fast, Super Fast | 3 setting speeds: regular set, fast set, and super fast set |
| Substantial Equivalence: Similar function and intended use to predicate device | Substantially equivalent to Kerr Corporation, Take 1 (marketed as Take 1 Advanced) |
Notes on "Acceptance Criteria" for this device:
- No quantitative statistical thresholds are explicitly stated because this is a Class II dental impression material cleared via substantial equivalence, not a high-risk device with specific performance endpoints like sensitivity/specificity for disease detection.
- The "acceptance criteria" here refer to matching the material composition, physical properties (viscosity, setting times), and intended use to a legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a "test set" in the context of evaluating a software algorithm or diagnostic device. The evaluation for substantial equivalence typically involves material characterization and comparison to the predicate, not a clinical study with a specified test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring expert-established ground truth for a test set of medical cases.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI-powered interpretation systems to evaluate the impact of the AI on human reader performance, which is not relevant for a dental impression material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental impression material, not an algorithm, so the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
Not applicable in the conventional sense of expert consensus, pathology, or outcomes data for diagnostic accuracy. For this type of device, the "ground truth" for demonstrating equivalence would be based on established dental material standards and performance data for the predicate device, as well as the physical and chemical properties of the new device confirming it performs as intended.
8. The Sample Size for the Training Set
No training set is mentioned or applicable. This is a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a machine learning model.
{0}------------------------------------------------
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
JAN 9 8 2010
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: July 2009
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
Device Description:
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and 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.
Substantial Equivalence:
Take 1 Advanced Rigid Tray is substantially equivalent to another legally marketed device in the United States. Take 1 Advanced Rigid Tray functions in a manner similar to and is intended for the same use as Take 1, marketed as Take 1 Advanced and manufactured by Kerr Corporation.
{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 stylized image of an eagle or other bird with three wing-like shapes. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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, Incorporated 1717 West Collins Avenue Orange, California 92867
JAN 2 8 2CC9
Re: K092176
Trade/Device Name: Take 1 Advanced Rigid Tray Regulation Number: 21CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: January 11, 2010 Received: January 12, 2010
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.
{2}------------------------------------------------
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/CDRHOffices/ucm11.15809.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 vours.
Th for
Anthony D. 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
{3}------------------------------------------------
Indications for Use
510{k) Number (if known):
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 _ X
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)
K. M. luy for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092176
Page 1 of 1
§ 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).