(94 days)
No
The summary describes a resin-based adhesive for orthodontic brackets and does not mention any AI or ML components or functionalities.
No
A therapeutic device is used to treat or prevent disease. This device is an adhesive used to bond orthodontic appliances to teeth, which is a supportive function and not directly therapeutic in itself.
No
The device is an adhesive used to bond orthodontic appliances, not to diagnose a condition. Its function is to attach brackets to teeth for treatment.
No
The device description clearly states it consists of a "resin-saturated mat" and is used for "bonding orthodontic appliances," indicating a physical, material-based product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in bonding orthodontic appliances for orthodontic treatment." This is a direct treatment application, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a resin-saturated mat used for bonding brackets to teeth. This is a physical adhesive for a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of APC™ Flash-Free Adhesive is as a light cure orthodontic adhesive that is designed to be used in bonding orthodontic appliances for orthodontic treatment.
APC™ Flash-Free Adhesive is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
DYH, NJM, EJF
Device Description
APC™ Flash-Free Adhesive is an adhesive pre-applied to orthodontic appliances for orthodontic treatment. It consists of a resin-saturated mat that is attached to the apprimated for Craceets, ceramic brackets, and bondable buccal tubes. The relatively low viscosity of the resin allows it to form a fillet at the edges of the bracket which reduces the need to remove excess adhesive, also known as flash.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance testing included:
- Bond strength test demonstrating comparable performance to predicate devices and providing minimum bond strength.
- Primer compatibility test demonstrating comparable performance with Transbond MIP Primer and Transbond Plus SEP Primer, providing minimum bond strength.
- Accelerated aging of bonds by thermocycling demonstrating comparable performance to predicate devices and providing minimum bond strength after specified cycles.
- Ambient light stability test demonstrating comparable performance to predicate devices and providing minimum bond strength after exposure to ambient light.
No clinical performance testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
510(k) Summary
FEB - 2 2012 14113197
ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter | 3M Unitek Corporation, 2724 South Peck Road, Monrovia,
CA 91016-5097 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Robert Wang, RAC
Regulatory Affairs
Phone: (800) 423-4588 Ext. 4997
(626) 574-4997 Direct
Fax: (626) 574-4894
E-mail: rwang24@mmm.com |
| Additional Contact persons | Kathleen F. Bacon
Global Regulatory Affairs Manager
Phone: (626) 574-4212
Fax: (626) 574-4894
E-mail: kbacon@mmm.com
Jerold S. Horn
Vice President, Quality and Regulatory
Phone: (626) 574-4462
Fax: (626) 574-4894
E-mail: jshorn1@mmm.com |
| Date Summary was Prepared | October 28, 2011 |
| Trade /Device Name | APC™ Flash-Free Adhesive |
| Common Name | Adhesive, Bracket and Tooth Conditioner, Resin |
| Classification Name | Bracket adhesive resin and tooth conditioner
(21 CFR 872.3750, Class II, Product Code: DYH,
Subsequent Product Code: NJM and EJF) |
Predicate Devices:
Company: 3M Unitek Corporation Device: Adhesive Precoated Brackets (K911271)
Company: 3M Unitek Corporation Device: APCTM Plus Adhesive (K020394)
Device Description:
Device Description. appliances for orthodontic treatment. It consists of a resin-saturated mat that is attached to the apprimated for Craceets, ceramic brackets, and bondable buccal tubes. The relatively low viscosity of the resin allows it to form a fillet at the edges of the bracket which reduces the need to remove excess adhesive, also known as flash.
1
Intended Use of The Device:
The intended use of APC™ Flash-Free Adhesive is as a light cure orthodontic adhesive that is designed to be used in bonding orthodontic appliances for orthodontic treatment.
Technological Characteristics:
APC™ Flash-Free is substantially equivalent in design features to the predicate devices. These features include an adhesive pre-applied to a bracket bonding base and then light-cured to adhere the appliance to the tooth.
Device Material:
APCTM Flash-Free Adhesive and the predicate devices Adhesive Precoated Brackets and APC™ Plus Adhesive are substantially equivalent in composition. All three devices contain methacrylate based resins and fillers. Additionally, all three devices are cured by exposure to visible light.
Device Design:
APC™ Flash-Free Adhesive and the predicate devices Adhesive Precoated Brackets and APC™ Plus Adhesive are substantially equivalent in design. All three devices consist of an orthodontic appliance which is delivered with a methacrylate-based adhesive precoated (pre-applied) to the bonding base and packaged in a heat sealed plastic blister. Further, all three devices are cured via exposure to visible light.
Nonclinical Performance Testing:
The nonclinical testing performance analysis shows that APC™ Flash-Free Adhesive performs comparably to the predicate devices as follows:
- The bond strength test demonstrates that Adhesive Precoated Brackets, APC™ Plus 1. Adhesive, and APC™ Flash-Free Adhesive perform comparably and provide the minimum bond strength to hold a bracket to a tooth.
-
- The primer compatibility test demonstrates that APC™ Plus Adhesive and APC™ Flash-Free Adhesive perform comparably and provide the minimum bond strength to hold a bracket to a tooth when used with Transbond MIP Primer (3M™ Dent System, K962785), and Transbond Plus SEP Primer (Modification to Prompt™ L-Pop™, K001494).
-
- Accelerated aging of bonds by thermocycling demonstrates that APC™ Plus Adhesive and APC™ Flash-Free Adhesive perform comparably and provide the minimum bond strength to hold a bracket to a tooth following a specified number of cycles between hot and cold environments.
-
- The ambient light stability test demonstrates that APC™ Plus Adhesive and APC™ Flash-Free Adhesive perform comparably and provide the minimum bond strength to hold a bracket to a tooth following exposure to ambient light.
Clinical Performance Testing:
No clinical performance testing was conducted with APC™ Flash-Free Adhesive.
2
Substantial Equivalence:
Information provided in this 510(k) submission ahows that APCTM Flash-Free Adhesive is substantially equivalent to the predicate devices, Adhesive Precoated Brackets and APC™ Plus Adhesive, in terms of intended use, indications for use, composition, performance and Adhesive, in terms of intended asse, increations drawn from the nonclinical performance (bench) testing and the biocompatibility assessment demonstrate that APC™ Flash-Free Adhesive is safe and effective for the circumputed use and performs as well as the predicate devices.
This 510(k) submission includes data from bench testing to evaluate the performance of APC™ Flash-Free Adhesive compared to the predicate devices. The properties evaluated include Flash-Free Aunch VC Compared to the processed Aging of Bonds by Thermocycling, and Ambient Light Stability.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with three lines coming from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Wang Regulatory Affairs 3M Unitek Corporation 2724 South Peck Road Monrovia, CA 91016-5097
FEB - 2 2012
· Re: K113197
Trade/Device Names: APC™ Flash-Free Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH, EJF, and NJM Dated: January 25, 2012 Received: January 26, 2012
Dear Mr. Wang:
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.
4
Page 2 - Mr. Wang
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 vours,
hh foi
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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APC™ Flash-Free Adhesive Traditional 510(k) Premarket Notification
Submitter: 3M Unitek Corporation
12 113 197
Indications for Use
510(k) Number (if known):
Device Name: APC™ Flash-Free Adhesive
Indications for Use:
APC™ Flash-Free Adhesive is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runyre
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113 197