PULPDENT PUTTY DAM

K022522 · Pulpdent Corporation · EIE · Sep 26, 2002 · Dental

Device Facts

• Record ID: K022522
• Device Name: PULPDENT PUTTY DAM
• Applicant: Pulpdent Corporation
• Product Code: EIE · Dental
• Decision Date: Sep 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1

Intended Use

PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.

Device Story

Pulpdent Putty Dam is a light-cured resin material used by dental professionals in clinical settings. The device is applied to soft tissue to create a physical barrier during dental procedures, specifically bleaching, air abrasion, and etching. By isolating the soft tissue, the device protects it from potential irritation or damage caused by the chemical or mechanical agents used in these procedures. The clinician applies the material, which is then cured using a light source to form a protective layer. After the procedure, the barrier is removed. The device benefits the patient by preventing accidental exposure of soft tissue to dental treatment agents.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by historical usage of similar materials over approximately 10 years and literature references (Reality, 2002).

Technological Characteristics

Light-cured resin material; functions as a physical barrier; applied manually by dental professionals; cured via light activation.

Indications for Use

Indicated for use by dental professionals to protect soft tissue by creating a physical barrier during bleaching, air abrasion, and etching procedures.

Regulatory Classification

Identification

A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.

Predicate Devices

• ULTRA DENT OPAL DAM
• DEN-MAT PAINT ON RUBBER DAM
• PREMIER PERFECTA BLOCK OUT RESIN
• SHOFU NIVEOUS LIQUID DAM
• LUMA LITE LUMA BLOCK
• INTERDENT FAST DAM
• BriteSmile BARRIER MATERIAL

Submission Summary (Full Text)

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# SEP 2 6 2002

510 k Premarket Notification Pulpdent PUTTY DAM

### EXHIBIT 2

KQ2522

### SUMMARY OF SAFETY AND EFFECTIVENESS DAT

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

Telephone: [phone] Fax: [phone] Email: [e-mail]

DEVICE NAME: PULPDENT PUTTY DAM

#### PREDICATE DEVICES:

ULTRA DENT OPAL DAM DEN-MAT PAINT ON RUBBER DAM PREMIER PERFECTA BLOCK OUT RESIN SHOFU NIVEOUS LIQUID DAM LUMA LITE LUMA BLOCK INTERDENT FAST DAM BriteSmile BARRIER MATERIAL

#### DESCRIPTION AND INTENDED USE:

PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.

#### COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT PUTTY DAM is substantially equivalent in composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

#### SAFETY AND EFFECTIVENESS:

General usage of these materials over about 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. The safety and effectiveness of these resins is supported by the editors of Reality. 2002. In addition, the predicate products listed above have been given 510 (k) Premarket approval as Class I Dental Devices under CFR 872.4565 and 872.6300. 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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SFP 26 2002

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P.O. Box 780 Watertown, Massachusetts 02472

Re: K022522

Trade/Device Name: Pulpdent Putty Dam Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: July 25, 2002 Received: July 30, 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.

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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 accurics. 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

Timothy A. Ulatowski

Timothy A Ulatowski 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

K022522

510 (k) Number (if known)

PULPDENT PUTTY DAM Device Name

Indications for Use:

PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
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| (Per 21 CFR 801.109) | |

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| Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | |

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