FLOW-RITE

K971594 · Pulpdent Corp. · EBF · Sep 12, 1997 · Dental

Device Facts

• Record ID: K971594
• Device Name: FLOW-RITE
• Applicant: Pulpdent Corp.
• Product Code: EBF · Dental
• Decision Date: Sep 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PULPDENT FLOW-RITE is a visible light cured flowable composite used a Class II, III, IV-and V restorative. It dispenses as a smooth paste with used as a Class if, III, I v ale 7 researcy for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.

Device Story

Pulpdent FLOW-RITE is a visible light-cured flowable composite dental restorative material. It is supplied as a smooth paste; applied by a clinician in a dental office setting to restore tooth structure in Class II, III, IV, and V cavities. The material is placed into the cavity preparation and cured using a visible light source for 30-40 seconds. The cured composite provides color stability, translucency for aesthetic blending, and polishability. It functions as a direct restorative material to replace lost tooth structure, potentially benefiting the patient by restoring dental function and aesthetics.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by reference to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, which indicates a high benefit-to-risk ratio for general usage of dental composites over approximately 20 years.

Technological Characteristics

Visible light-cured flowable composite material. Curing time: 30-40 seconds. Form factor: flowable paste. Class II device.

Indications for Use

Indicated for use as a restorative material for Class II, III, IV, and V dental restorations.

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 OBA
• Seal-Rite
• Seal-Rite Low Viscosity
• Bisco Aeliteflo
• E&D / Kerr Revolution

Submission Summary (Full Text)

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Ka71594

SEP 1 2 1997

## EXHIBIT 8

## RESPONSE TO SMDA OF 1990

## SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA

TELEPHONE: [phone] [phone] FAX

## DEVICE NAME: Pulpdent FLOW-RITE

Pulpdent OBA, Seal-Rite, Seal-Rite Low Viscosity, PREDICATE DEVICE: Pulodent Hybrid Anterior Composite Bisco Aeliteflo E&D / Kerr Revolution

DESCRIPTION AND INTENDED USE: Pulpdent FLOW-RITE is a visible light cured flowable composite material. It dispenses as a smooth paste with excellent working properties and translucency for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully. Intended use: Class II, III, IV, and V restorations.

COMPARISON WITH PREDICATE PRODUCTS: Pulpdent FLOW-RITE is substantially equivalent in composition and/or intended use to the above mentioned predicate products. Please see EXHIBIT 5 for the entire comparison.

SAFETY AND EFFECTIVENESS: 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-to-risk ratio...both composites and glass ionomers are relatively trouble free. There is no evidence of short or long term risk... there is no suspicion of any problems after literally billions of procedures in the United States." Please see EXHIBIT 6 for the complete papers from the conference.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 1997

Mr. Kenneth J. Berk Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02272

K971594 Re: Flow-Rite Trade Name: Requlatory Class: II Product Code: EBF Dated: July 14, 1997 Received: July 21, 1997

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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 obligation you might have under sections 531

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Page 2 - Mr. Berk

through 542 of the Act for devices under the Electronic Chrough 542 Of the Act 101 acrises or other Federal laws or regulations.

This letter will allow you to begin marketing your device as This recei will arrow your of the motification. The FDA described in your 510 tr, premation of your device to a legally marketed predicate device results in a classification for your marketed predicate device robadewice to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advice i additionally 809.10 for in regulation (21 crk rares), please contact the Office of Villo draghosere actroob, , , , , , , , , , questions on Compilance at [phone]. In and advice, please contact che promocion and adversionig o1 [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene reger notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance oblained from ene brough [phone] or [phone] or at at its coll free namber (s://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim M. Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

**510(k) Number (if known):** K9715-94

**Device Name:** PULPDENT FLOW-RITE

Indications For Use:

PULPDENT FLOW-RITE is a visible light cured flowable composite used a Class II, III, IV-and V restorative. It dispenses as a smooth paste with used as a Class if, III, I v ale 7 researcy for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K971594 |
| Prescription Use | Yes |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | No |
| (Optional Format 1-2-96) | |