(167 days)
Not Found
No
The summary describes a chemical adhesive and its physical properties, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
No
The device is an adhesive used for bonding orthodontic brackets to teeth, which is a supportive material for a therapeutic device (orthodontic brackets) but not a therapeutic device itself.
No
The device is an adhesive for bonding orthodontic brackets, not for diagnosing medical conditions. Its described function is therapeutic/restorative (bonding), and the performance studies focus on physical properties relevant to adhesion, not diagnostic accuracy.
No
The device description and performance studies clearly indicate this is a physical adhesive product, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "direct bonding of orthodontic bracket to tooth structure." This is a therapeutic/restorative procedure performed directly on the patient's body.
- Device Description: The device is a "resin based adhesive designed for direct bonding of orthodontic brackets." This describes a material used for physical attachment within the mouth.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue samples, etc., to detect diseases, conditions, or physiological states.
- Performance Studies: The performance studies focus on physical properties like hardness, bond strength, and set time, which are relevant to its function as an adhesive, not a diagnostic tool.
Therefore, this device falls under the category of a dental adhesive used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step. This product can be used for patients of all ages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure
Indicated Patient Age Range
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 the DMRC Self-Cure Bracket Adhesive One Step and Primer included the following:
- Vicker's Hardness
- . Shear Bond Strength on enamel (MPa)
- . Self-Cure Set Time (Min)
Results of our bench testing indicate that DMRC Self-Cure Bracket Adhesive One Step and Primer was equivalent to the predicate device.
Biocompatibility testing: cytotoxicity testing of device extract performed according to ISO 10993-5, 2009 and ISO 10993-12, 2012. The device extract was found to be not cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Test Method | DMRC Self-Cure Bracket Adhesive and Primer | System 1+ and Activator (Ormco) |
|---|---|---|
| Vicker's Hardness | 37 (5) | 29 (3) |
| Shear Bond Strength on enamel (MPa) | 6.7 (1) | 5.2 (0.7) |
| Self-Cure Set Time (min) | 2:30 | 2:00 |
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
§ 872.3750 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2015
Danville Materials, LLC. Ms. Dong Hua Regulatory Affairs Director and QA Manager 3420 Fostoria Way, Suite A200 San Ramon, California 94583
Re: K142886
Trade/Device Name: DMRC Self-cure Bracket Adhesive One Step and Primer Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: Class II Product Code: DYH Dated: February 18, 2015 Received: February 20, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K142886
Device Name
DMRC Self-Cure Bracket Adhesive One Step and Primer
Indications for Use (Describe)
This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure
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 features a square graphic on the left with a stylized design resembling a starburst or radiating lines. 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
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 Danville Materials LLC Name:
- A Address: 3420 Fostoria Way Suite A-200 San Roman, CA 94583 USA
- A Contact Person: Dong Hua
- A Title: Regulatory Affair Director and QA Manager
- A 800-827-7940/925-973-0710. Ext. 212 Phone:
-
Fax: 925-973-0764
-
Date Summary Prepared: March 9, 2015
B. The Name of the Device:
- A Trade/Proprietary Name: DMRC Self-Cure Bracket Adhesive One Step and Primer
- 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 K941015 ORMCO SYSTEM 1+ (TM) By ORMCO CORP
D. Description of the Device:
The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step. This product can be used for patients of all ages.
E. Indication For Use:
The DMRC Self-Cure Bracket Adhesive One Step and Primer is a one step, no mix adhesive for direct bonding of orthodontic bracket to tooth structure
F. A comparison of the ORMCO SYSTEM 1+ (TM) by ORMCO CORP and the DMRC Self-Cure Bracket Adhesive One Step and Primer to determine SE:
- A The equivalence to the predicate device is supported by the physical performance
4
Image /page/4/Picture/0 description: The image is a logo for Danville Engineering & Materials. The logo features a square graphic on the left side, which contains a stylized image of what appears to be a sun or starburst. 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
testing
- Chemicals, function of each component of the product are identified A
- A Similarities in the Indications for Use:
| Product | 510(K)
Number | Classification Name | Indications For Use |
|-----------------------------------------------------------|------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| ORMCO SYSTEM 1+ (TM) | K941015 | Adhesive, Bracket and
Tooth Conditioner,
Resin | Self-Cure orthodontic bracket adhesive
used with a liquid primer and enamel
etching gel to adhere orthodontic
brackets to tooth surfaces |
| DMRC Self-Cure Bracket
Adhesive One Step and
Primer | New
(K142886) | Adhesive, Bracket and
Tooth Conditioner,
Resin | A one step no-mix adhesive for direct
bonding of orthodontic bracket to tooth
structure |
- A Discussion of Non-Clinical and Clinical Tests performed for Determination of Substantial Equivalence:
The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step. The materials used in The DMRC Self-Cure Bracket Adhesive One Step and Primer are the same as used by our predicate, ORMCO SYSTEM 1+ (TM) By ORMCO CORP (K941015), which is the 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 the DMRC Self-Cure Bracket Adhesive One Step and Primer included the following:
- Vicker's Hardness
- . Shear Bond Strength on enamel (MPa)
- . Self-Cure Set Time (Min)
There is no specific standard is used. Results of our bench testing indicate that DMRC Self-Cure Bracket Adhesive One Step and Primer was equivalent to the predicate device.
| Test Method | DMRC Self-Cure Bracket
Adhesive and Primer | System 1+ and Activator
(Ormco) |
|----------------------------------------|-----------------------------------------------|------------------------------------|
| Vicker's Hardness | 37 (5) | 29 (3) |
| Shear Bond Strength on
enamel (MPa) | 6.7 (1) | 5.2 (0.7) |
| Self-Cure Set Time (min) | 2:30 | 2:00 |
The subject device was determined to be substantial equivalent to the predicate in terms of biocompatibility, based on a risk assessment and the identification of legally marketed predicate devices for all ingredients in the chemical composition, as well as cytotoxicity testing
5
Image /page/5/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a square graphic on the left with a stylized sun or starburst design inside. To the right of the graphic, the word "Danville" is written in a bold, sans-serif font, and below that, the words "ENGINEERING & MATERIALS" are written in a smaller, sans-serif font.
3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA
of device extract performed according to ISO 10993-5, 2009 and ISO 10993-12, 2012. The device extract was found to be not cytotoxic.
Conclusion: G.
In conclusion, the subject device, the DMRC Self-Cure Bracket Adhesive One Step and Primer 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 Self-Cure Bracket Adhesive One Step and Primer is as safe and effective as the predicate device, and may be released to the market.