PULPDENT ETCH-RITE ROYALE

K031915 · Pulpdent Corporation · KLE · Aug 5, 2003 · Dental

Device Facts

• Record ID: K031915
• Device Name: PULPDENT ETCH-RITE ROYALE
• Applicant: Pulpdent Corporation
• Product Code: KLE · Dental
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is a dark blue color for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement, and rinses completely without leaving any gel residue or color on the tooth.

Device Story

Pulpdent Etch-Rite Royale is a 37% phosphoric acid etching gel; used by dental professionals in clinical settings to prepare tooth surfaces (dentin/enamel) for restoration. Dark blue color provides contrast for visualization; soft gel consistency allows precise application without running or flowing. Rinses completely without residue. Benefits include improved bonding surface preparation for restorative procedures.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by over 10 years of usage history of the predicate products.

Technological Characteristics

37% phosphoric acid in a soft gel carrier. Dark blue dye for visualization. Non-flowable consistency. Class II dental device.

Indications for Use

Indicated for dental professionals to etch dentin or enamel prior to tooth restoration.

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 Semi-Gel Etchant 35% Phosphoric acid Etchant
• Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel

Submission Summary (Full Text)

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## AUG - 5 2003

510 k Premarket Notification Pulpdent Etch-Rite Royale

## EXHIBIT 2

K031915

### SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

| DEVICE NAME: | PULPDENT ETCH-RITE ROYALE |
|--------------------|-------------------------------------------------------|
| PREDICATE DEVICES: | Pulpdent Semi-Gel Etchant 35% Phosphoric acid Etchant |
| | Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel |

#### DESCRIPTION AND INTENDED USE:

Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is a dark blue color for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement, and rinses completely without leaving any gel residue or color on the tooth.

#### COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent Etch-Rite Royale is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

#### SAFETY AND EFFECTIVENESS:

General usage of the predicate products over more than 10 years indicates a high benefit-to-risk ratio. There is no evidence of short-term or long-term risk or suspicion of any problems. In addition, the predicate products listed above have been given 510 (k) Premarket approval as Class II Dental Devices under CFR 872.3690. Please see Exhibit 4 for 510(k) numbers.

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Public Health Service

AUG - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re: K031915

Trade/Device Name: Pulpdent Etch-Rite Rovale Regulation Number: 21 CFR 872.3200 Regulation Name: Resin, Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 13, 2003 Received: June 24, 2003

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.

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.

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Page 2 - Mr. Kenneth J. 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); 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runnr

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATIONS FOR USE STATEMENT

11-031915

510 (k) Number (if known)

Device Name Pulpdent Etch-Rite Royale

#### Indications for Use:

Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert S. Betz DDS for Dr. K. Mulry

(Division Sign-Off) Division of Anesthesiology, General Hospi Infection Control, Dental De

510(k) Number: K031915

or

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use