PULPDENT UNO-DUO

K993683 · Pulpdent Corp. · KLE · Dec 13, 1999 · Dental

Device Facts

• Record ID: K993683
• Device Name: PULPDENT UNO-DUO
• Applicant: Pulpdent Corp.
• Product Code: KLE · Dental
• Decision Date: Dec 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

PULPDENT UNO-DUO is a kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNO-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which a dual cure product is indicated.

Device Story

PULPDENT UNO-DUO is a dental adhesive kit comprising a light-cure primer/bonding resin and a dual-cure catalyst. Used by dentists in clinical settings to facilitate bonding to dentin, enamel, metals, and resins. The device provides a dual-cure capability for restorative procedures where light-curing alone may be insufficient or preferred. The system is based on technology licensed from the ADA Health Foundation. The clinician applies the material to the prepared tooth surface or restorative material to achieve adhesion. The device benefits patients by providing a reliable bonding interface for dental restorations, reducing the risk of restoration failure.

Clinical Evidence

No clinical data provided. Effectiveness is supported by research performed at the ADA Health Foundation, published research papers, and evaluations by the editors of Reality (1999). The device relies on the established safety profile of dental restorative materials used for over 20 years.

Technological Characteristics

Dental adhesive kit containing a single-component light-cure primer/bonding resin and a dual-cure catalyst. Based on ADA Health Foundation research. Class II dental device (21 CFR 872.3690).

Indications for Use

Indicated for use by dentists to bond to dentin, enamel, metals, and resins in clinical situations requiring a self-cure or dual-cure dental adhesive system.

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 UNO
• PULPDENT DENTASTIC
• Dentsply / Caulk PRIME & BOND NT DUAL CURE

Submission Summary (Full Text)

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DEC 1 3 1999

## EXHIBIT 2

RESPONSE TO SMDA OF 1990

### SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

617-926-6666 617-926-6262

DEVICE NAME: PULPDENT UNO-DUO

PREDICATE DEVICES:

PULPDENT UNO PULPDENT DENTASTIC Dentsply / Caulk PRIME & BOND NT DUAL CURE

#### DESCRIPTION AND INTENDED USE:

PULPDENT UNO-DUO is a kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNC-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which helshe prefers a self-cure or dual cure product.

DenTASTIC UNO-DUO is based on the same technology from the American Dental Association (ADA) Health Foundation as Pulpdent DenTASTIC (Parts A, B and C) and Pulpdent DenTASTIC UNO. The formula for this product is based on research done by the ADA Health Foundation. Pulpdent manufactures DenTASTIC and DenTASTIC UNO under license from the ADA Health Foundation.

#### COMPARISON WITH PREDICATE PRODUCTS:

DenTASTIC UNC-DUO is substantially equivalent in composition and intended use to the abovementioned predicate product. Please see Exhibit 5 for the entire comparison.

#### SAFETY AND EFFECTIVENESS:

All of the components used in DenTASTIC UNO-DUO have been used in legally marketed predicate dental devices.

According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio...[they] are relatively trouble-free. There is no evidence of short-term or long-term risk... There is no suspicion of any problems after virtually billions of procedures in the United States.

The effectiveness of this type of adhesive system is supported by research performed at the ADA Health Foundation, by research papers, and by evaluation by the editors of Reality, 1999. In addition, the predicate product listed above has been given 510 (k) Premarket approval as Class II Dental Devices under CFR 872.3690 Please see Exhibit 5 for full comparison and 510(k) numbers and Exhibit 10 for references.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 1899

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

> Re : K993683 Pulpdent UNO-DUO Trade Name: Requlatory Class: II Product Code: KLE Dated: October 22, 1999 November 1, 1999 Received:

Dear Mr. Berk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Berk

obligation you might have under sections 531 through 542 of obligation you might have the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debeling of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markeed production permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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 origios or centitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdp.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATE

K993683

510 (k) Number (if known)

PULPDENT DENTASTIC UNO-DUO KIT Device Name

Indications for Use:

PULPDENT DENTASTIC UNO-DUO is a kit containing DenTASTIC UNO, a singlecomponent light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNO-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which a dual cure product is indicated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Susan Runne

Over-The-Counter Use

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .