(134 days)
Not Found
No
The summary describes a chemical adhesive material and its physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a dental adhesive used for bonding orthodontic bands, not for therapy or treatment of any condition. It functions as a material to secure a medical device (orthodontic bands) to the patient.
No.
The device is an adhesive for bonding orthodontic bands, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description clearly states it is a resin-based material, which is a physical substance, not software. The performance studies also focus on material properties like hardness and bond strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding orthodontic bands to enamel. This is a direct application to the patient's tooth structure for a therapeutic purpose (orthodontic treatment).
- Device Description: The description details a resin-based material for cementation, a physical process of bonding.
- Lack of In Vitro Testing: The description of performance studies focuses on physical properties (hardness, bond strength, work/set times) and biocompatibility (cytotoxicity). There is no mention of testing biological samples (blood, urine, tissue, etc.) outside of the body to diagnose or monitor a condition.
- Anatomical Site: The anatomical site is enamel, which is part of the patient's body. IVDs typically analyze samples taken from the body.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
DMRC Dual Cure Orthodontic Band Cement is a dual-cure adhesive intended for use as an orthodontic band cement for bonding of orthodontic bands to enamel
Product codes
DYH
Device Description
DMRC Dual Cure Orthodontic Band Cement is a resin based material containing a dual-cure adhesive for cementation of orthodontic bands. The DMRC Dual Cure Orthodontic Band Cement is a polymer based filling and restorative material; it contains a base and catalyst for dual curing process as orthodontic band cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel
Indicated Patient Age Range
This product can be used for patients of all ages.
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)
Non-Clinical Testing performed on DMRC Dual Cure Orthodontic Band Cement included the following:
- Vickers Hardness
- Ultradent Bracket Shear Bond Strength
- Work and Set times for Orthodontic Products
- ISO 10993 testing for Cytotoxicity
All testing performed on the DMRC Dual Cure Orthodontic Band Cement was derived from the risk assessment which evaluated the effects of the feature changes. The efficacy or suitability to the intended purpose of DMRC Dual Cure Orthodontic Band Cement has been demonstrated by a combination of in-house testing and side-by-side comparisons to the predicate device currently on the market. Results of our bench testing indicate that DMRC Dual Cure Orthodontic Band Cement performs as well as the predicate device currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
Danville Materials, LLC Ms. Dong Hua Regulatory Affair Director and QA Manager 3420 Fostoria Way, Suite A-200 San Ramon, CA 94583
Re: K142881
Trade/Device Name: DMRC Dual Cure Orthodontic Band Cement Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: January 13, 2015 Received: January 15, 2015
Dear Ms. Hua:
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.
1
Page 2 - Ms. Dong Hua
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142881
Device Name
DMRC Dual Cure Orthodontic Band Cement
Indications for Use (Describe)
DMRC Dual Cure Orthodontic Band Cement is a dual-cure adhesive intended for use as an orthodontic band cement for bonding of orthodontic bands to enamel
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo consists of a square graphic on the left and the company name on the right. The square graphic is a dark blue color and contains a white design that resembles a sun or starburst. The company name is written in a bold, black font, with the word "Danville" appearing on the top line and "ENGINEERING & MATERIALS" appearing on the bottom line in a smaller font.
3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA
510(K) Summary
This summary of the Traditional 510(K) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92
A. Applicant's Name and Address
- A Name: Danville Materials LLC
- A Address: 3420 Fostoria Way Suite A-200 San Roman, CA 94583 USA
- A Contact Person: Dong Hua
- A Regulatory Affair Director and QA Manager Title:
- A Phone: 800-827-7940/925-973-0710. Ext. 212
-
925-973-0764 Fax:
- Date Summary Prepared: January 13, 2015 A
B. The Name of the Device:
- A Trade/Proprietary Name: DMRC Dual Cure Orthodontic Band Cement
- A The common name of the device: Dental adhesive, bracket and tooth conditioner, Resin
- A The Classification Name: Bracket adhesive resin and tooth conditioner per 21 CFR 872.3750, product Code DYH has been classified under section 513 of the Act as a Class II device
C. Legally Marketed Predicate Device to Which Substantial Equivalence (SE) is claimed:
- A K073697 Transbond Supreme Adhesive By 3M Unitek
D. Description of the Device:
DMRC Dual Cure Orthodontic Band Cement is a resin based material containing a dual-cure adhesive for cementation of orthodontic bands. The DMRC Dual Cure Orthodontic Band Cement is a polymer based filling and restorative material; it contains a base and catalyst for dual curing process as orthodontic band cement. This product can be used for patients of all ages. The materials used in DMRC Dual Cure Orthodontic Band Cement are the same as used by our predicates, Transbond Supreme Adhesive By 3M Unitek (K073697), which is the similar dental adhesive Product. The raw chemical materials have been widely used by numerous manufacturers in the medical/dental industry.
4
Image /page/4/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a square graphic on the left, with a stylized design of radiating lines. To the right of the graphic, the word "Danville" is written in a bold, sans-serif font. Below "Danville", the words "ENGINEERING & MATERIALS" are written in a smaller, sans-serif font.
www.danvillematerials.com
3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA
- A Indication For Use: The DMRC Dual Cure Orthodontic Band Cement is a dual-cure adhesive intended for use as an orthodontic band cement for bonding of orthodontic bands to enamel.
- E. A comparison of the Transbond Adhesive Products by 3M Unitek and the DMRC Dual Cure Orthodontic Band Cement to determine SE:
- A The equivalence to the predicate device is supported by the physical performance testing
- A Chemicals, function of each component of the product are identified
- A Similarities in the Indications for Use:
| Product | 510(K) Number | Classification Name | Indications For Use |
|---|---|---|---|
| 3M Unitek's | |||
| Transbond Supreme | |||
| Adhesive | K073697 | Bracket Adhesive Resin | |
| and Tooth Conditioner | Light cure orthodontic adhesive designed | ||
| for bonding brackets and other bondable | |||
| appliances to etched enamel | |||
| DMRC Dual Cure | |||
| Orthodontic Band | |||
| Cement | K142881 | Bracket Adhesive Resin | |
| and Tooth Conditioner | A dual-cure adhesive intended for use as | ||
| an orthodontic band cement for bonding | |||
| of orthodontic bands to enamel |
- A Discussion of Non-Clinical and Clinical Tests performed for Determination of Substantial Equivalence:
DMRC Dual Cure Orthodontic Band Cement is a resin based material containing a dualcure adhesive for cementation of orthodontic bands. The materials used in DMRC Dual Cure Orthodontic Band Cement are the same as used by our predicate, Transbond Supreme Adhesive By 3M Unitek (K073697), which is a similar dental adhesive product. The raw chemical materials have been widely used by numerous manufacturers in the medical/dental industry.
Non-Clinical Testing performed on DMRC Dual Cure Orthodontic Band Cement included the following:
- Vickers Hardness
- Ultradent Bracket Shear Bond Strength ●
- Work and Set times for Orthodontic Products
- ISO 10993 testing for Cytotoxicity
All testing performed on the DMRC Dual Cure Orthodontic Band Cement was derived from the risk assessment which evaluated the effects of the feature changes. The efficacy or suitability to the intended purpose of DMRC Dual Cure Orthodontic Band
5
Image /page/5/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo consists of a square graphic on the left, which contains a pattern of lines radiating from a central point. To the right of the graphic is the word "Danville" in a bold, sans-serif font. Below "Danville" are the words "ENGINEERING & MATERIALS" in a smaller, sans-serif font.
www.danvillematerials.com
3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA
Cement has been demonstrated by a combination of in-house testing and side-by-side comparisons to the predicate device currently on the market. Results of our bench testing indicate that DMRC Dual Cure Orthodontic Band Cement performs as well as the predicate device currently on the market.
Discussion of Clinical Tests performed:N/A
F. Conclusion:
Our records indicate that our predicates have been used by dentists and large group practices in the United States and purchased by a large number of international distributors.
In conclusion, the subject device, DMRC Dual Cure Orthodontic Band Cement has been designed and manufactured with the intended use and claims for the product in mind. The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness. The DMRC Dual Cure Orthodontic Band Cement is as safe and effective as the predicate device, and may be released to the market.