ETCH-RITE SUPREME

K120213 · Pulpdent Corporation · KLE · Mar 30, 2012 · Dental

Device Facts

• Record ID: K120213
• Device Name: ETCH-RITE SUPREME
• Applicant: Pulpdent Corporation
• Product Code: KLE · Dental
• Decision Date: Mar 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Pulpdent Etch-Rite Supreme is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.

Device Story

Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etching gel; used by dental professionals in clinical settings for tooth restoration. The device is applied to dentin, enamel, or glass ionomers to prepare the surface for bonding. The dark purple color provides contrast for visualization; the soft gel consistency allows flow through 25-gauge applicator tips and facilitates easy rinsing. The device functions as a chemical etchant; it does not involve electronic components, software, or automated analysis. Clinical benefit is derived from effective surface preparation for restorative materials, supported by over 20 years of experience with the Etch-Rite product line.

Clinical Evidence

Bench testing only. Performance metrics include specific gravity (1.280), water solubility (100%), and pH (1.0). No clinical data provided.

Technological Characteristics

36% phosphoric acid, silica gel, and propylene glycol composition. Soft gel form factor. Applied via 25-gauge pre-bent applicator tip. Dark purple colorant for visualization. Non-electronic, chemical-based etching agent.

Indications for Use

Indicated for use by dental professionals for etching dentin, enamel, or glass ionomers during tooth restoration 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-Rite™ 38% Phosphoric Acid Etching Gel (K882576)
• Pulpdent Etch Royale™ 37% Phosphoric Acid Etching Gel (K031915)

Submission Summary (Full Text)

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MAR 3 0 2012

-

・

80 Oakland Street Watertown, MA 02472 USA

TEL: [phone] FAX: [phone] [e-mail]

## 510(k) Summary

January 17, 2012

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: [phone] Fax: [phone] Email: [e-mail]

| DEVICE NAME: | PULPDENT ETCH-RITE™ SUPREME |
|----------------------|-----------------------------|
| CLASSIFICATION NAME: | Resin tooth bonding agent |
| FDA PRODUCT CODE: | KLE, CFR 872.3200 |

PULPDENT C

PREDICATE DEVICES: Pulpdent Etch-Rite™ 38% Phosphoric Acid Etching Gel Pulpdent Etch Royale™ 37% Phosphoric Acid Etching Gel

#### DESCRIPTION:

Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in a soft gel that does not dry out quickly, that flows through small applicator tips and that washes off readily. Etch-Rite Supreme is colored dark purple for contrast with tooth enamel and easy visualization.

#### INTENDED USE

Pulpdent Etch-Rite Supreme is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.

#### COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent Etch-Rite Supreme is substantially equivalent in design, composition and intended use to the predicate products that have been given 510(k) Premarket approval as Class II Dental Devices under CFR 872.3200.

| | Pulpdent<br>Etch-Rite Supreme | Pulpdent<br>Etch-Rite | Pulpdent<br>Etch Royale |
|--------------------------|-------------------------------------------------------|--------------------------------------------------|-----------------------------------------------|
| | | K882576 | K031915 |
| Chemical<br>Composition: | 36% Phosphoric Acid<br>Silica gel<br>Propylene glycol | 38% Phosphoric Acid<br>Silica gel | 37% Phosphoric Acid<br>Glycerin<br>Silica Gel |
| Consistency | Soft gel | Thixotropic gel | Soft gel |
| Applicator tip | 25 gauge, pre-bent | 25 gauge, pre-bent | 25 gauge, pre-bent |
| Color | Dark purple | Blue | Dark blue |
| Intended Use | Etch dentin, enamel and<br>glass ionomer cements | Etch dentin, enamel and<br>glass ionomer cements | Etch dentin and tooth<br>enamel. |

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### PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

TEL: [phone] FAX: [phone] [e-mail]

# 510(k) Summary

#### Summary of Performance Testing - Bench

The following test results demonstrate that Etch Supreme performs as intended:

| Specific gravity | 1.280 |
|---------------------|------------------------------------------------|
| Solubility in water | 100 % |
| pH | 1.0 |
| Appearance and odor | Dark purple gel with mild, characteristic odor |
| Shelf-Life | Two years |

#### CONCLUSION:

From the above comparisons, the bench testing, a search of the relevant scientific literature and the organizational experience with the Etch-Rite line of etchants, it can be concluded that Etch-Rite Supreme is substantially equivalent in design, composition, performance and intended use to the predicate products. General usage of Etch-Rite for more than 20 years and Etch Royale for over 10 indicates a high benefit-to-risk ratio.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street Watertown, MA 02472

MAR 3 0 2012

Re: K120213

Trade/Device Name: Pulpdent Etch-Rite™ Supreme Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: January 17, 2012 Received: January 24, 2012

Dear Mr. Berk:

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 - Mr. Berk:

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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# Indications for Use

20213

# 510(k) Number (if known):

Device Name: Pulpdent Etch-Rite ™ Supreme

# Indications For Use:

Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k062613

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