PULPDENT SEMI-GEL ETCH

K022492 · Pulpdent Corporation · EBF · Oct 11, 2002 · Dental

Device Facts

• Record ID: K022492
• Device Name: PULPDENT SEMI-GEL ETCH
• Applicant: Pulpdent Corporation
• Product Code: EBF · Dental
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

PULPDENT SEMI-GEL ETCH is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.

Device Story

Pulpdent Semi-Gel Etch is a 35% phosphoric acid etchant in viscous liquid form. Used by dental professionals in clinical settings to prepare tooth surfaces (dentin, enamel) and glass ionomer cements for restorative procedures. The device acts as a chemical etching agent to modify surface topography, facilitating bonding. It is applied directly by the clinician. The product is a chemical formulation; no electronic or mechanical components are involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the established safety and effectiveness of predicate phosphoric acid etching gels with over 10 years of clinical use.

Technological Characteristics

35% phosphoric acid etchant in a viscous liquid form. Class II dental device (CFR 872.3690).

Indications for Use

Indicated for use by dental professionals to etch dentin, enamel, and glass ionomer cements.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel
• Pulpdent Etch-All 10 % Phosphoric Acid Etching Gel
• Ortho Direct Enamel Etch

Submission Summary (Full Text)

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### PU .PDENT CORPORATION

510 k Premarket Notification Pulpdent Semi-Gel Etch

## EXHIBIT 2

OCT 1 1 2002

#### SUMMARY OF SAFETY AND EFFECTIVENESS DATA

K022492

Kenneth J. Berk 80 Oakland Street P J Box '80 V 'atertown, MA 02472 USA

617-926-6666 Telephone: [phone] Fax: Email: [e-mail]

| DEVICE NAME: | PULPDENT Semi-Gel Etch |
|--------------------|-----------------------------------------------------|
| PREDICATE DEVICES: | Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel |
| | Pulpdent Etch-All 10 % Phosphoric Acid Etching Gel |
| | Ortho Direct Enamel Etch |

#### DESCRIPTION AND INTENDED USE:

Pulpdent Semi-Gel Etch is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.

#### COMF ARISON WITH PREDICATE PRODUCTS:

PULP DENT Semi-Gel Etch is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

#### SAFE TY AND EFFECTIVENESS:

Gene al 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2002

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

Re: K022492

Trade/Device Name: Pulpdent Semi-Gel Etch Regulation Number: 872.3670 Regulation Name: Resin Impression Tray Material Regulatory Class: II Product Code: 76 EBF Dated: July 25, 2002 Received: July 29, 2002

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.

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.

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Page 2 -- Mr. Berk

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.

Patricia Cicconetti, ffe

Timothy A. Ulatowski 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 STATEMENT

K022492

510 (k) Numbe (if known)

Device Na me

# PULPDENT SEMI-GEL ETCH

## Indi >ations for Use:

PULPDENT SEMI-GEL ETCH is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cem ents.

F'lease do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Frescription Use_ (i?er 21 CFR 801.109) or

Over-The-Counter Use

R.Betz DDS for Dr. S. Lunner

Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number. K022492