e-1 etchants

K152110 · E Dental Products · KLE · Nov 20, 2015 · Dental

Device Facts

• Record ID: K152110
• Device Name: e-1 etchants
• Applicant: E Dental Products
• Product Code: KLE · Dental
• Decision Date: Nov 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Etch enamel, dentin, and glass ionomer cements

Device Story

E Dental Products e-1 etchants are 37% phosphoric acid aqueous gels used in dental restorative procedures. The device is supplied in a syringe and applied directly to the tooth surface via an applicator tip. It is used by dental professionals to etch enamel, dentin, and glass ionomer cements to prepare the tooth surface for bonding. The gel is rinsed off after application. The device functions as a chemical etchant to modify tooth structure, facilitating subsequent restorative material adhesion.

Clinical Evidence

Bench testing only. Performance testing compared pH, solubility, specific gravity, appearance, shelf life, and odor against the predicate device. Results demonstrated equivalence across all tested parameters.

Technological Characteristics

37% phosphoric acid aqueous gel; contains silica and colorant. Form factor: syringe with applicator tip. Shelf life: 2 years. No electronic or software components.

Indications for Use

Indicated for etching enamel, dentin, and glass ionomer cements in dental restorative procedures.

Regulatory Classification

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.

Predicate Devices

• Pulpdent Etch-Royale (K031915)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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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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 [phone] (M-F 8-5 only) Contact: Dr. Jeff Banyas 216 W. Watauga Ave Johnson City, TN 37604 USA 423-426-3221 fax [phone] (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

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### 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<br>e-1 etchants<br>K152110 | Pulpdent Etch Royale<br>K031915 |
|-------------------------|------------------------------------------------------|-------------------------------------------------------|
| Chemical<br>composition | 37% phosphoric acid<br>silica<br>colorant | 37% phosphoric acid<br>silica<br>glycerin<br>colorant |
| Consistency | soft gel | soft gel |
| Color | colored | dark blue |
| Intended use | Etch enamel, dentin<br>and glass ionomer<br>cements. | Etch enamel, dentin<br>and glass ionomer<br>cements. |

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## 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<br>e-1 etchants<br>K152110 | Pulpdent Etch-Royale<br>K031915 |
|-----------------------------|----------------------------------------------|---------------------------------|
| Specific gravity<br>@ 25C | 1.31 | 1.30 |
| Solubility in water<br>@25C | 100% | 100% |
| pH @25C | 1 | 1 |
| appearance | colored<br>soft gels | dark blue<br>soft gel |
| shelf life | 2 years | 2 years |
| odor | mild characteristic | mild characteristic |

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### 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.