(71 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a phosphoric acid gel, with no mention of AI or ML.
No
The device is used to prepare tooth material by etching, which is a pre-restoration step. It is not described as treating, preventing, or mitigating a disease or condition, which are characteristics of a therapeutic device.
No
The device is used for preparing tooth material by etching the surface prior to restoration. This is a treatment/preparation function, not a diagnostic one.
No
The device description explicitly states it is a water-based gel containing phosphoric acid, which is a physical substance, 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 "Preparation of tooth material prior to restoration by etching of the surface." This is a procedure performed directly on the tooth, not on a sample taken from the body for diagnostic purposes.
- Device Description: The device is a "water-based gel containing 40% phosphoric acid." This is a chemical agent used for surface treatment, not a reagent or instrument used to analyze biological samples.
- Anatomical Site: The anatomical site is "Tooth material," which is treated directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The performance studies focus on chemical composition and physical properties, not diagnostic accuracy.
IVD devices are 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 disease or other conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Preparation of tooth material prior to restoration by etching of the surface.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
The device described in this 510(k) consists of a water-based gel containing 40% phosphoric acid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth material
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)
Technological characteristics and non-clinical performance data provided in this 510(k) consist of chemical composition. description of product packaging/delivery mechanism, and physical properties measurements (pH, viscosity and specific gravity). The Etch Gel is either the same as or equivalent to the predicate device in terms of these technological characteristics and non-clinical performance data.
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.
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
| Date: | July 11, 2013 | JUL 1 1 2013 |
|---|---|---|
| Owner's Name: | ||
| Address: | DMG America, LLC | |
| 242 South Dean Street | ||
| Englewood, NJ 07631 | ||
| (201) 894-5500 | ||
| Contact Person: | Pamela Papineau, RAC | |
| Delphi Medical Device Consulting, Inc. | ||
| 5 Whitcomb Avenue | ||
| Ayer, MA 01432 | ||
| (978) 772-3552 | ||
| Subject Device: | ||
| Trade Name: | ||
| Common Name: | ||
| Classification Name: | Etch Gel | |
| Dental etching gel | ||
| Resin Bonding Agent | ||
| (21 CFR 872.3200, Product Code KLE; Class II) | ||
| Predicate Device: | ||
| Trade Name: | Zenith 40% Phosphoric Acid Gel (Foremost Dental | |
| Mfg, Inc.) | ||
| Common Name: | ||
| Classification Name: | ||
| Premarket Notification: | Dental etching gel | |
| Sealant, Pit and Fissure, and Conditioner | ||
| (21 CFR 872.3765, Product Code EBF; Class II) | ||
| K890464 |
Product Description:
The device described in this 510(k) consists of a water-based gel containing 40% phosphoric acid.
Indications for Use
Preparation of tooth material prior to restoration by etching of the surface.
Substantial Equivalence
Substantial Equivalence for the DMG America, LLC Etch Gel is based upon comparison to the physical properties, material composition, description of product packaging/delivery mechanism and indications for use of the predicate device. Technological characteristics and non-clinical performance data provided in this 510(k) consist of chemical composition. description of product packaging/delivery mechanism, and physical properties measurements (pH, viscosity and specific gravity). The Etch Gel is either the same as or equivalent to the predicate device in terms of these technological characteristics and non-clinical performance data.
Conclusion:
The Etch Gel has been shown to be substantially equivalent in safety and effectiveness to the predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2013
DMG America, LLC C/O Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K131248
Trade/Device Name: Etch Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 20, 2013 Received: May 01, 2013
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. 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. 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); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division 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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BMG Asserica, LLC 510(k) Premarket Notileation (Traditions
20 February 2013 Etch Ge
Section 4 - Indications for Use Statement
510(k) Number (if known):
Device Name: Etch Gel
Indications for Use:
Preparation of tooth material prior to restoration by etching of the surface.
Prescription Use _X (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)
Mary S. Runner -S
Susan R DOS MA 2013.07.11
15:06:33 -04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: 4131248
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