(62 days)
Not Found
No
The description focuses on the chemical composition and physical properties of the impression material, with no mention of AI or ML.
No.
The device is an impression material used to create molds of the oral cavity, which is a diagnostic tool, not a therapeutic one.
No
Explanation: The device is an impression material used to create molds of teeth and surrounding structures, not to identify or diagnose a disease or condition.
No
The device description clearly states it is a system of vinylpolysiloxane impression materials, which are physical substances used to create dental impressions. This is a hardware-based device, 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 impressions of the oral cavity (teeth and surrounding structures) for dental procedures (crown and bridge, edentulous, and implant impressions). This is a physical impression of anatomical structures, not a test performed on biological samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the chemical composition and physical properties of the impression material. It does not describe a test or assay for detecting substances or conditions in biological samples.
- Performance Studies: The performance studies focus on biocompatibility and physical properties of the material (work time, set time, strain in compression, etc.), which are relevant to its function as an impression material, not as a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a dental impression material, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Take 1 Advanced is a complete system of vinylpolysiloxane impression materials suitable for all crown and bridge, edentulous and implant impressions.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Toke 1 Advonced is a complete system of vinylpolysiloxane impression materials composed of addition silicone chemistry where reaction between vinyl-terminated polydimethyl siloxane and poly-hydrogen siloxane catalyzed by platinum complex catalyst generates an optimum elastomeric material suitable for all crown and bridge, edentulous and implant impressions. The Take 1 Advanced system of materials is available in five viscosities, four delivery options, and in a range of set times. Take 1 Advanced has high elongation for easy mouth removal while its elastic recovery and tear strength provide accurate, detailed impressions time after time. The Wash viscosities are available in both Cartridge and Unidose syringe, a single use delivery system. The Tray viscosity is available in both Cartridge and Volume 5:1 delivery, for use in automated dynamic mixing machines. Take 1 Advonced offers three setting speeds: Regular Set, Fast Set, and Super Fast Set. Take 1 Advanced Putty is also available for Putty/Wash technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, teeth, dentition, soft tissues
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)
Biocompatibility studies were completed which demonstrate that the material is safe for its intended use. Take 1 Advanced was tested through the following tests: Agar Diffusion Test- ISO Direct Contact, ISO Kligman Maximization Test and ISO Oral Irritation Test.
The 510(k) submission also includes data from bench testing used to evaluate performance characteristics of Take 1 Advanced as compared to the predicate device, Take 1 currently marketed by Kerr Corporation. The characteristics evaluated include Method of Manipulation, Work Time, Set Time, Strain in Compression, Deformation Recovery, Mixed Paste Consistency, Dimensional change, Hardness (Shore A), Compatibility with Die/Cast Material, Tensile Strength, Tensile Elongation, Tear Strength and Contact Angle.
Clinical testing has not been conducted on this product.
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.
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
130869
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The word 'Submitter' is written below 'SYBRON DENTAL SPECIALTIES'.
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person
March 2013 Date Summary Prepared:
- Trade name Take 1 Advanced .
- Common name Dental Impression Material .
- Classification name Impression Material, per 21 CFR 872.3660 .
- Product Code ELW o
510(k) Summary
Devices for Which Substantial Equivalence is Claimed:
- Take 1, Kerr Corporation, K091613 o
Device Description
Toke 1 Advonced is a complete system of vinylpolysiloxane impression materials composed of addition silicone chemistry where reaction between vinyl-terminated polydimethyl siloxane and poly-hydrogen siloxane catalyzed by platinum complex catalyst generates an optimum elastomeric material suitable for all crown and bridge, edentulous and implant impressions. The Take 1 Advanced system of materials is available in five viscosities, four delivery options, and in a range of set times. Take 1 Advanced has high elongation for easy mouth removal while its elastic recovery and tear strength provide accurate, detailed impressions time after time. The Wash viscosities are available in both Cartridge and Unidose syringe, a single use delivery system. The Tray viscosity is available in both Cartridge and Volume 5:1 delivery, for use in automated dynamic mixing machines. Take 1 Advonced offers three setting speeds: Regular Set, Fast Set, and Super Fast Set. Take 1 Advanced Putty is also available for Putty/Wash technique.
Indications for Use
Take 1 Advanced is a complete system of vinylpolysiloxane impression materials suitable for all crown and bridge, edentulous and implant impressions.
$\checkmark$
MAY 3 0 2013
1
Summary of Technological Characteristics ·
で
| Descriptive
Information | Take 1 Advanced | Take 1
K091613 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Kerr Corporation | Kerr Corporation |
| Indications for Use | Take 1 Advanced is a complete
system of vinylpolysiloxane
impression materials suitable for
all crown and bridge, edentulous
and implant impressions. | Take 1 is an addition-cure vinly
polysiloxane dental impression
material that is used for all
crown and bridge, edentulous,
orthodontic and implant
impression techniques. |
| Description of
Material | Vinly Polysiloxane | Vinly Polysiloxane |
| Mode of Use | 1. Take 1 Advanced Light
body/Regular body wash:
A very hydrophilic impression
material used in heavy/wash or
putty/wash impression
procedures and capable of
capturing extraordinary
subgingival details. It is used in
crown and bridge and all high
precision applications.
2. Take 1 Advanced Medium body:
A medium viscosity monophase
impression material with
superior mechanical strength
used in single step impression
procedures such as mouth
guards, night guards,
orthodontic, and edentulous
applications.
3. Take 1 Advanced Tray:
A heavy body impression
material combining strength,
elasticity and dimensional
stability to deliver the most
accurate impressions. It is used
in two-step heavy-wash
applications such as for crown
and bridge procedures. | 1. Take 1 Light body/Regular
body wash:
A very hydrophilic impression
material used in heavy/wash
or putty/wash impression
procedures and capable of
capturing extraordinary
subgingival details. It is used
in crown and bridge and all
high precision applications.
2. Take 1 Medium body:
A medium viscosity
monophase impression
material with superior
mechanical strength used in
single step impression
procedures such as mouth
guards, night guards,
orthodontic, and edentulous
applications.
3. Take 1 Tray:
A heavy body impression
material combining strength,
elasticity and dimensional
stability to deliver the most
accurate impressions. It is
used in two-step heavy-wash
applications such as for crown
and bridge procedures. |
| Descriptive
Information | Take 1 Advanced | Take 1
K091613 |
| Principles of
Operation | Take 1 Advanced is a dental
impression that takes imprints of
hard (teeth) and/or soft tissues.
Take 1 Advanced captures a part
or all of a person's dentition and
surrounding structures of oral
cavity. The dental impression
forms an imprint (i.e. a 'negative'
mold) of teeth and soft tissues,
which can then be used to make
a cast of the dentition. An
impression is made by placing a
viscous, thixotropic impression
material into the mouth via a
dental impression tray. The
material, then sets to become an
elastic solid, and, when removed
from the mouth, provides a
detailed and stable negative of
teeth. | Take 1 is a dental impression
that takes imprints of hard
(teeth) and/or soft tissues. Take 1
captures a part or all of a
person's dentition and
surrounding structures of oral
cavity. The dental impression
forms an imprint (i.e. a 'negative'
mold) of teeth and soft tissues,
which can then be used to make
a cast of the dentition. An
impression is made by placing a
viscous, thixotropic impression
material into the mouth via a
dental impression tray. The
material, then sets to become an
elastic solid, and, when removed
from the mouth, provides a
detailed and stable negative of
teeth. |
| Shelf-Life | 3 years | 3 years |
·
)
2
Non-Clinical Performance Data
Biocompatibility studies were completed which demonstrate that the material is safe for its intended use. Take 1 Advanced was tested through the following tests: Agar Diffusion Test- ISO Direct Contact, ISO Kligman Maximization Test and ISO Oral Irritation Test.
The 510(k) submission also includes data from bench testing used to evaluate performance characteristics of Take 1 Advanced as compared to the predicate device, Take 1 currently marketed by Kerr Corporation. The characteristics evaluated include Method of Manipulation, Work Time, Set Time, Strain in Compression, Deformation Recovery, Mixed Paste Consistency, Dimensional change, Hardness (Shore A), Compatibility with Die/Cast Material, Tensile Strength, Tensile Elongation, Tear Strength and Contact Angle.
Clinical Testing
Clinical testing has not been conducted on this product.
3
Conclusion
: 1 .
Based upon the biocompatibility tests and bench testing, the clinical performance of Take 1 Advanced is substantially equivalent to the predicate device.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 30, 2013
Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K130869
Trade/Device Name: Take 1 Advanced Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 28, 2013 Received: April 01, 2013
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-(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.
5
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 devicerelated 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 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/Resourcesfor You/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
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 4
Indications for Use Statement
Kerr Corporation - Take 1 Advanced - 510(k) Submission
.
Section 004 - Page 1 of 2 ·
......... .
7
Indications for Use Statement
.
43,8669 510(k) Number (if known):
Device Name: Take 1 Advanced
Indications For Use:
Take 1 Advanced is a complete system of vinylpolysiloxane impression materials suitable for all crown and bridge, edentulous and implant impressions.
Prescription Use_ × (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)
Susan Runner, DDS, MA
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K130869 |
|---|---|
| ---------------- | --------- |
Kerr Corporation - Take 1 Advanced - 510(k) Submission