(125 days)
Not Found
No
The document describes a dental bonding agent and does not mention any AI or ML capabilities.
No.
The device is indicated for bonding resin-based materials to tooth structure and treating hypersensitive teeth, which is a dental material/adhesive for restorative procedures, not a therapeutic device.
No
This device is a dental bonding agent used for bonding resin-based materials to tooth structure and treating hypersensitive teeth. It is not used to diagnose a medical condition.
No
The device description explicitly states it consists of "two dental bonding agent formulations," which are physical chemical substances, 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 for bonding dental materials to tooth structure and treating hypersensitive teeth. This is a direct application to the patient's body (in vivo), not for testing samples taken from the body (in vitro).
- Device Description: The device is a dental bonding agent, a material applied directly to the tooth.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Total-Etch Dualbond is indicated for:
- Bonding resin-based materials (especially dual-cure composite / compomer . materials) to tooth structure (dentin and enamel)
- Treatment of hypersensitive teeth .
Total-Etch Bond is indicated for:
- Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel)
- Treatment of hypersensitive teeth .
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
The Total Etch Bonding Agent consists of two dental bonding agent formulations for use in dual- and light-cured bonding procedures:
Total-Etch Bonding Agent for Dual-Cured Resin-Based Materials (Total-Etch Dualbond) Total-Etch Bonding Agent for Light-Cured Resin-Based Materials (Total-Etch Bond)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure (dentin and enamel)
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)
This submission contains safety and performance information (chemical composition and physical performance data) sufficient to establish substantial equivalence in comparison to the devices listed above.
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.
K003293, Unknown, K910628, K942493, K041960
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
510(k) Summary
| Trade Name: | Total Etch Bonding Agent (Total-Etch Bond & Total-
Etch Dual-Bond) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DMG USA, Inc.
23 Frank Mossberg Drive
Attleboro, MA 02703
Registration # not yet assigned
Owner/Operator No. 9005969 |
| Device Generic Name: | Dental Bonding Agent |
| Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II. |
Product Description:
The Total Etch Bonding Agent consists of two dental bonding agent formulations for use in dual- and light-cured bonding procedures:
Total-Etch Bonding Agent for Dual-Cured Resin-Based Materials (Total-Etch Dualbond) Total-Etch Bonding Agent for Light-Cured Resin-Based Materials (Total-Etch Bond)
Indications for Use:
Total-Etch Dualbond is indicated for
- Bonding resin-based materials (especially dual cure composite, compomer . materials) to tooth structure (dentin and enamel)
- . Treatment of hypersensitive teeth
Total-Etch Bond is indicated for
- Bonding resin-based materials (especially light cure composite, compomer . materials) to tooth structure (dentin and enamel)
- . Treatment of hypersensitive teeth
Predicate Devices:
The components of the proposed Post and Core Kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:
| Product Name | Predicates |
|---|---|
| Excite DSC | K003293 (Ivoclar North America Inc.) |
| Optibond Solo Plus (Dual-cure) | Unknown (Kerr Mfg. Co.) |
| All Bond 2 | K910628 (Bisco) |
| Scotchbond MP Plus | K942493 (3M Espe) |
Total-Etch Dualbond:
1
Total-Etch Bond:
| Product Name | Predicate |
|---|---|
| Contax bonding agent contained in | |
| the DMG Composite / Compomer | |
| Repair Kit | K041960 (DMG - USA) |
Safety and Performance:
This submission contains safety and performance information (chemical composition and physical performance data) sufficient to establish substantial equivalence in comparison to the devices listed above.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Total Etch Bond has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
MAR 2 0 2007
Re: K063444
Trade/Device Name: Total Etch Bonding Agent (Total Etch Bond & Total Etch Dual Bond) Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 01, 2007 Received: March 07, 2007
Dear Ms. Papineau:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Pamela Papineau
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clair S. Lizio, Ph.D.
Chiu S. Lin. PhD 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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Page _ 1 of
510(k) Number (if known): K063444
Device Name: Total Etch Bonding Agent (Total Etch Bond & Total Etch Dual Bond)
Indications for Use:
Total-Etch Dualbond is indicated for:
- Bonding resin-based materials (especially dual-cure composite / compomer . materials) to tooth structure (dentin and enamel)
- Treatment of hypersensitive teeth .
Total-Etch Bond is indicated for:
- Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel)
- Treatment of hypersensitive teeth .
Prescription Use × (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use (Per 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)
Sunor Teare
f Arkansas Building, General Hospital,
Infection Control, Clean Devices
July 26
00013