(114 days)
No
The device is a chemical etchant and the description and performance studies focus on its chemical properties and equivalence to a predicate device, with no mention of AI or ML.
No.
The device functions as an etchant for dental procedures, preparing the tooth surface for restoration rather than treating a disease or condition itself.
No
Explanation: The device is an etchant used in tooth restoration. Its intended use is to etch enamel, dentin, and glass ionomer cements, which is a preparatory step for dental procedures rather than a diagnostic one. It does not identify a disease, condition, or provide a diagnosis.
No
The device description clearly states it is a "colored 37% phosphoric acid aqueous solution etching gels," which is a chemical 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 to "Etch enamel, dentin, and glass ionomer cements." This is a direct application to biological material in situ (on the tooth) for a therapeutic or restorative purpose, not for the diagnosis of a condition.
- Device Description: The description confirms it's an "etching gel" applied as a "step in the tooth restoration process." This further supports its use in a dental procedure, not for diagnostic testing.
- Lack of Diagnostic Purpose: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing information about a patient's health status or condition. IVDs are specifically designed to perform tests on samples to aid in diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a dental material used in a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Etch enamel, dentin, and glass ionomer cements.
Product codes
KLE
Device Description
E Dental Products e-1 etchants are colored 37% phosphoric acid aqueous solution etching gels. E Dental Products e-1 etchants are dispensed from a syringe with the addition of an applicator tip and they are easily rinsed off. E-1 etchants are applied to be a step in the tooth restoration process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel, dentin, and glass ionomer cements (part of tooth)
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
It was confirmed that the pH value, solubility in water, specific gravity, appearance, shelf life and odor of the subject devices were equivalent to the predicate device.
The following test results demonstrate that E Dental Products e-1 etchants perform as intended. Accordingly, it was concluded that the performance and shelf life of the subject devices were substantially equivalent to those of the predicate device.
| E Dental Products e-1 etchants K152110 | Pulpdent Etch-Royale K031915 | |
|---|---|---|
| Specific gravity @ 25C | 1.31 | 1.30 |
| Solubility in water @25C | 100% | 100% |
| pH @25C | 1 | 1 |
| appearance | colored soft gels | dark blue soft gel |
| shelf life | 2 years | 2 years |
| odor | mild characteristic | mild characteristic |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
E Dental Products Jeff Banyas, DDS Owner 216 W. Watauga Ave. Johnson City, Tennessee 37604
Re: K152110
Trade/Device Name: E Dental Products e-1 Etchants Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 15, 2015 Received: August 25, 2015
Dear Dr. Banvas:
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
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 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
510(k) Number (if known) K152110
Device Name E Dental Products e-1 etchants
Indications for Use (Describe)
Etch enamel, dentin, and glass ionomer cements
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)
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3
216 West Watauga Ave. Johnson City, TN 37604
Image /page/3/Picture/13 description: The image shows a logo for eDentalProducts.com. The logo features a stylized letter "C" that is three-dimensional and has a gradient fill of green and blue. The website address, "eDentalProducts.com," is written in a sans-serif font below the logo.
E Dental Products 1-844-289-3824
510(k) Summary
November 17, 2015
7a. 510(k) Submitter/Contact:
Owner: E Dental Products 216 W. Watauga Ave. Johnson City, TN 37604 USA 423-426-3221 fax 423-928-0266 (M-F 8-5 only) Contact: Dr. Jeff Banyas 216 W. Watauga Ave Johnson City, TN 37604 USA 423-426-3221 fax 423-928-0266 (M-F 8-5 only)
7b. Name of device:
Trade name - E Dental Products e-1 etchants 510(k) number - K152110 Classification name - Resin tooth bonding agent 21 CFR 872.3200 Product code KLE Common Name - phosphoric acid gel etch
7c. Predicate Device:
Trade name - Pulpdent Etch-Royale 510(k) Number - K031915 Resin tooth bonding agent Classification: Product code: KLE 21 CFR 872.3200 Common name - phosphoric acid gel etch
4
7d. Description:
E Dental Products e-1 etchants are colored 37% phosphoric acid aqueous solution etching gels. E Dental Products e x etenation of an applicator tip and they are easily rinsed off e-1 etchants are upplied to be step in the tooth restoration process.
7e. Indications for Use:
Etch enamel, dentin, and glass ionomer cements.
7f. Comparison with predicate:
E Dental Products e-1 etchants are substantially equivalent in design, composition, E Defrance, and intended use to the predicate device that has been give 510(k) clearance as a Class II Dental Device under CFR 872.3200.
| | E Dental Products
e-1 etchants
K152110 | Pulpdent Etch Royale
K031915 |
|-------------------------|------------------------------------------------------|-------------------------------------------------------|
| Chemical
composition | 37% phosphoric acid
silica
colorant | 37% phosphoric acid
silica
glycerin
colorant |
| Consistency | soft gel | soft gel |
| Color | colored | dark blue |
| Intended use | Etch enamel, dentin
and glass ionomer
cements. | Etch enamel, dentin
and glass ionomer
cements. |
5
7g. Substantial Equivalence Discussion:
Intended uses
The intended uses of the subject devices and predicate are identical. Accordingly, the intended uses of the subject devices are substantially equivalent to that of the predicate device.
Chemical Ingredients
E Dental Products e-1 etchants and the predicate device contain the same concentrations of phosphoric acid and both contain silica and colorant. All ingredients in the subject devices are substantially equivalent to the predicate device. Regarding the predicate device, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US. In conclusion, it can be said that the subject device is substantially equivalent to that of the predicate device.
Technological Characteristics
There is no difference between indications for use between the subject devices and the predicate device. There is no difference between the subject devices and the predicate device in regards to technology; as the active ingredient, phosphoric acid, is the same in both the subject devices and the predicate device.
E Dental Products e-1 etchants and the predicate device are both filled in syringes. Both subject devices and predicate device are applied directly to the tooth through a dispensing tip.
7h. Summary of Performance Testing - Bench
lt was confirmed that the pH value, solubility in water, specific gravity, appearance, shelf life and odor of the subject devices were equivalent to the predicate device.
The following test results demonstrate that E Dental Products e-1 etchants perform as intended. Accordingly, it was concluded that the performance and shelf life of the subject devices were substantially equivalent to those of the predicate device.
| | E Dental Products
e-1 etchants
K152110 | Pulpdent Etch-Royale
K031915 |
|-----------------------------|----------------------------------------------|---------------------------------|
| Specific gravity
@ 25C | 1.31 | 1.30 |
| Solubility in water
@25C | 100% | 100% |
| pH @25C | 1 | 1 |
| appearance | colored
soft gels | dark blue
soft gel |
| shelf life | 2 years | 2 years |
| odor | mild characteristic | mild characteristic |
6
7i. Biocompatibility:
The subject devices are categorized into an external communicating device that may contact dentin and whose duration is less than 24 hours. Actual contact with the dentin is 15 seconds and 30 seconds with enamel and glass ionomer cements.
Biocompatibility testing was not conducted because of the similarity in composition between the predicate device and the subject devices and no new chemical components have been added.
The subject devices and predicate device are substantially equivalent in all relevant aspects, are composed of equivalent materials, and have equivalent manufacturing methods.
Regarding the predicate device, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.
Accordingly, it was determined that the subject devices were substantially equivalent to the predicate device.
7j. Conclusion:
Based on technological characteristics, non-clinical performance data, and side by side comparisons of the subject devices to the predicate device, it can be concluded that E Dental Products e-1 etchants are substantially equivalent in design, composition, performance, and intended use to the predicate device that has been given 510(k) clearance as Class II dental device under CFR 872.3200.