(107 days)
Not Found
No
The description focuses on the material properties and clinical applications of a dental composite, with no mention of AI or ML.
No
The device is a dental material used for restoration and sealing, not a therapeutic device designed to treat a disease or medical condition.
No
This device is described as a core build-up material, a restorative material, and a cementing agent. Its intended use is to repair and restore teeth, not to diagnose conditions.
No
The device description clearly indicates it is a physical material (composite) used for dental procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the material being used directly on vital and non-vital teeth for various dental procedures (core build-up, sealing, lining, cementation, restoration, dentin replacement). This is a therapeutic or restorative use, not a diagnostic one.
- Device Description: The description focuses on the material's properties and how it functions within the mouth (dual-cure, self-adhesive, fluoride release, flow characteristics, physical properties). It doesn't mention any diagnostic function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Anatomical Site: The anatomical site is teeth, which are the target of the treatment, not the source of a diagnostic sample.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a material used in the body for treatment and restoration.
N/A
Intended Use / Indications for Use
Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material.
Product codes
EBF
Device Description
Build-It Total Core is a dual-cure, self-adhesive composite with a continuous fluoride release. Build-It Total Core utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Ideal flow characteristics, esthetic and contrast shades, and outstanding physical properties make Build-It Total Core an indispensable tool in every clinician's armamentarium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vital and non-vital teeth
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: A biocompatibility study was completed, which demonstrates that the material is safe for its intended use. This 510(k) submission also includes data from bench testing used to evaluate performance characteristics of Build-It Total Core compared to the predicate devices, Build-It F.R. and Cement-It All Purpose currently marketed by Pentron Clinical as Breeze. The characteristics evaluated include water absorption and solubility, flexural and compression strength, linear expansion in water, fluoride release, and bond strength.
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Kl02703.
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized 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 logo is in black and white.
JAN - 5 2011
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue ! Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared:
December 2010
Device Name:
- · Trade Name Build-It Total Core
- Common Name Dental Composite Restorative Material
- · Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690
Devices for Which Substantial Equivalence is Claimed:
Device Description:
Build-It Total Core is a dual-cure, self-adhesive composite with a continuous fluoride release. Build-It Total Core utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Ideal flow characteristics, esthetic and contrast shades, and outstanding physical properties make Build-It Total Core an indispensable tool in every clinician's armamentarium.
Intended Use of the Device: (
Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Substantial Equivalence:
Build-It Total Core is substantially equivalent to two other legally marketed devices in the United States. Build-It Totol Core functions in a manner similar to and is intended for the same use as Build-It F.R, manufactured by Pentron Clinical. Its self-adhering properties are equivalent to Cement-It All Purpose, currently marketed by Pentron Clinical as Breeze. Build-It Total Core is similar to Build-It F.R in that it is a fiber reinforced, dual cure post and core build-up resin composite material which is used for tooth restorations. Build-It Total Core differs from Build-It F.R in that it utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Build-it Total Core is similar to Cement-It All Purpose, a self-adhering dental cement currently marketed by Pentron Clinical as Breeze, in that it has a similar formulation and it has self-adhering properties.
Non-Clinical Test Data
A biocompatibility study was completed, which demonstrates that the material is safe for its intended use. This 510(k) submission also includes data from bench testing used to ēvaluate performance characteristics of Build-It Total Core compared to the predicate devices, Build-It F.R. and Cement-It All Purpose currently marketed by Pentron Clinical as Breeze. The characteristics evaluated include water absorption and solubility, flexural and compression strength, linear expansion in water, fluoride release, and bond strength.
Clinical Testing
Clinical testing has not been conducted on this product.
Conclusion:
Based upon the biocompatibility studies and similar technological/performance characteristics as compared to the predicate devices, the clinical performance of Build-It Total Core is deemed to be substantially equivalent to the predicate devices, Build-It F.R. and Cement-It All Purpose currently marketed by Pentron Clinical as Breeze.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
Re: K102703
Trade/Device Name: Build-It Total Core Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 6, 2010 Received: December 7, 2010
JAN - 5 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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh 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
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Indications for Use
510(k) Number (if known): K102703
JAN - 5 2011
Device Name: Build-It Total Core
Indications For Use:
Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material.
| Prescription Use | X |
|---|---|
| (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 | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices Page 1 of 1 | |
| 1 510(k) Number: | K182703 |