(167 days)
This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure
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 document describes the DMRC Self-Cure Bracket Adhesive One Step and Primer and its substantial equivalence to a predicate device based on non-clinical testing.
Here's the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative sense with pass/fail thresholds. Instead, it presents the results of bench testing for the DMRC Self-Cure Bracket Adhesive One Step and Primer alongside the predicate device's performance to demonstrate "equivalence." The implied acceptance criterion is that the new device's performance is comparable to or better than the predicate device.
| Test Method | DMRC Self-Cure Bracket Adhesive and Primer (Reported Performance) | System 1+ and Activator (Ormco) (Predicate Device Performance) |
|---|---|---|
| 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 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of specimens tested) for the Vicker's Hardness, Shear Bond Strength, or Self-Cure Set Time tests. It also does not explicitly mention the country of origin of the data or whether the data was retrospective or prospective. These were non-clinical bench tests, not human studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The "test set" here refers to non-clinical bench tests on materials, not a set of clinical cases requiring expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable for non-clinical bench tests. The results are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This product is a dental adhesive, and the evaluation was based on non-clinical material properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is the quantitative measurement obtained through standardized laboratory testing procedures for properties like Vicker's Hardness, Shear Bond Strength, and Self-Cure Set Time.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/machine learning device.
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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.
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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
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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)
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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
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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 andTooth Conditioner,Resin | Self-Cure orthodontic bracket adhesiveused with a liquid primer and enameletching gel to adhere orthodonticbrackets to tooth surfaces |
| DMRC Self-Cure BracketAdhesive One Step andPrimer | New(K142886) | Adhesive, Bracket andTooth Conditioner,Resin | A one step no-mix adhesive for directbonding of orthodontic bracket to toothstructure |
- 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 BracketAdhesive and Primer | System 1+ and Activator(Ormco) |
|---|---|---|
| Vicker's Hardness | 37 (5) | 29 (3) |
| Shear Bond Strength onenamel (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
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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.
§ 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.