TAKE 1 ADVANCE

K130869 · Sybron Dental Specialties · ELW · May 30, 2013 · Dental

Device Facts

• Record ID: K130869
• Device Name: TAKE 1 ADVANCE
• Applicant: Sybron Dental Specialties
• Product Code: ELW · Dental
• Decision Date: May 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Take 1 Advanced is a complete system of vinylpolysiloxane impression materials suitable for all crown and bridge, edentulous and implant impressions.

Device Story

Take 1 Advanced is a vinylpolysiloxane (VPS) dental impression material system; utilizes addition silicone chemistry (platinum-catalyzed reaction between vinyl-terminated polydimethyl siloxane and poly-hydrogen siloxane). Available in five viscosities, four delivery options (cartridge, unidose syringe, volume 5:1), and three setting speeds (Regular, Fast, Super Fast). Used by dental professionals in clinical settings to capture negative imprints of hard (teeth) and soft oral tissues. Material is placed into the mouth via dental impression tray; sets into an elastic solid. Removed from mouth to provide detailed negative mold for subsequent cast fabrication. Benefits include high elongation for easy removal, elastic recovery, and tear strength for accurate, detailed impressions.

Clinical Evidence

No clinical data. Substantial equivalence established via biocompatibility testing (Agar Diffusion, Kligman Maximization, Oral Irritation) and comparative bench testing of physical/mechanical properties against the predicate device.

Technological Characteristics

Vinylpolysiloxane (addition silicone) impression material. Platinum complex catalyst. Viscous, thixotropic. Available in five viscosities and multiple delivery formats (cartridge, syringe, 5:1 automated mixing). Shelf-life: 3 years. Biocompatible per ISO standards.

Indications for Use

Indicated for patients requiring dental impressions for crown and bridge, edentulous, and implant procedures. No specific age or gender contraindications noted.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Take 1 (K091613)

Submission Summary (Full Text)

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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 [phone] - Phone [phone] - 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.

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MAY 3 0 2013

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#### Summary of Technological Characteristics ·

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| Descriptive<br>Information | Take 1 Advanced | Take 1<br>K091613 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Kerr Corporation | Kerr Corporation |
| Indications for Use | Take 1 Advanced is a complete<br>system of vinylpolysiloxane<br>impression materials suitable for<br>all crown and bridge, edentulous<br>and implant impressions. | Take 1 is an addition-cure vinly<br>polysiloxane dental impression<br>material that is used for all<br>crown and bridge, edentulous,<br>orthodontic and implant<br>impression techniques. |
| Description of<br>Material | Vinly Polysiloxane | Vinly Polysiloxane |
| Mode of Use | 1. Take 1 Advanced Light<br>body/Regular body wash:<br>A very hydrophilic impression<br>material used in heavy/wash or<br>putty/wash impression<br>procedures and capable of<br>capturing extraordinary<br>subgingival details. It is used in<br>crown and bridge and all high<br>precision applications.<br>2. Take 1 Advanced Medium body:<br>A medium viscosity monophase<br>impression material with<br>superior mechanical strength<br>used in single step impression<br>procedures such as mouth<br>guards, night guards,<br>orthodontic, and edentulous<br>applications.<br>3. Take 1 Advanced Tray:<br>A heavy body impression<br>material combining strength,<br>elasticity and dimensional<br>stability to deliver the most<br>accurate impressions. It is used<br>in two-step heavy-wash<br>applications such as for crown<br>and bridge procedures. | 1. Take 1 Light body/Regular<br>body wash:<br>A very hydrophilic impression<br>material used in heavy/wash<br>or putty/wash impression<br>procedures and capable of<br>capturing extraordinary<br>subgingival details. It is used<br>in crown and bridge and all<br>high precision applications.<br>2. Take 1 Medium body:<br>A medium viscosity<br>monophase impression<br>material with superior<br>mechanical strength used in<br>single step impression<br>procedures such as mouth<br>guards, night guards,<br>orthodontic, and edentulous<br>applications.<br>3. Take 1 Tray:<br>A heavy body impression<br>material combining strength,<br>elasticity and dimensional<br>stability to deliver the most<br>accurate impressions. It is<br>used in two-step heavy-wash<br>applications such as for crown<br>and bridge procedures. |
| Descriptive<br>Information | Take 1 Advanced | Take 1<br>K091613 |
| Principles of<br>Operation | Take 1 Advanced is a dental<br>impression that takes imprints of<br>hard (teeth) and/or soft tissues.<br>Take 1 Advanced captures a part<br>or all of a person's dentition and<br>surrounding structures of oral<br>cavity. The dental impression<br>forms an imprint (i.e. a 'negative'<br>mold) of teeth and soft tissues,<br>which can then be used to make<br>a cast of the dentition. An<br>impression is made by placing a<br>viscous, thixotropic impression<br>material into the mouth via a<br>dental impression tray. The<br>material, then sets to become an<br>elastic solid, and, when removed<br>from the mouth, provides a<br>detailed and stable negative of<br>teeth. | Take 1 is a dental impression<br>that takes imprints of hard<br>(teeth) and/or soft tissues. Take 1<br>captures a part or all of a<br>person's dentition and<br>surrounding structures of oral<br>cavity. The dental impression<br>forms an imprint (i.e. a 'negative'<br>mold) of teeth and soft tissues,<br>which can then be used to make<br>a cast of the dentition. An<br>impression is made by placing a<br>viscous, thixotropic impression<br>material into the mouth via a<br>dental impression tray. The<br>material, then sets to become an<br>elastic solid, and, when removed<br>from the mouth, provides a<br>detailed and stable negative of<br>teeth. |
| Shelf-Life | 3 years | 3 years |

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#### 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.

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### Conclusion

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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.

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#### 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 [phone] or [phone] 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 [phone] or [phone] 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

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## SECTION 4

# Indications for Use Statement

Kerr Corporation - Take 1 Advanced - 510(k) Submission

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Section 004 - Page 1 of 2 ·

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Indications for Use Statement

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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 |
|----------------|---------|
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Kerr Corporation - Take 1 Advanced - 510(k) Submission