Pulpdent DenTASTIC UNO is a single component dental adhesive primer and bond enhancer used by the dental professional to bond to dentin, enamel, metals and resins.

Device Description

Pulpdent DenTASTIC UNO is a single component dental adhesive primer and bond enhancer used by the dental professional to bond to dentin, enamel, metals and resins. The formula for Pulpdent DenTASTIC UNO is similar to that for Pulpdent Bond Enhancer [K926074. K931710. K953272. K953301] which was developed by the American Dental Association Health Foundation. The products are manufactured under license from that organization.

AI/ML Overview

This request cannot be fulfilled as the provided document {0} - {3} does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission summary for a dental adhesive, focusing on its substantial equivalence to predicate devices and general safety information, not specific performance metrics or clinical study details as requested.

Summary

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PULPDENT DENTASTIC UNO

EXHIBIT 7 RESPONSE TO SMDA OF 1990

DEC 17 1997

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

TELEPHONE: (617) 926-6666 (617) 926-6262 FAX:

Pulpdent DenTASTIC UNO DEVICE NAME:

Pulpdent Dental Bond Enhancer (DenTASTIC) PREDICATE DEVICES: Bisco One Step DenMat Tenure Quick Dentsply/Caulk Prime and Bond 2.1

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent is substantially equivalent in composition and 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 ... [they] ... 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.

Furthermore, according to several research papers, this type of adhesive system (PMGDM adhesive monomer) is an effective and reliable adhesive for dentin and enamel. The results of independent laboratory and clinical studies demonstrate the bond strength of the Pulpdent formula (DenTASTIC) for this adhesive system. Please see EXHIBIT 6 for the complete papers.

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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 stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | 7

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02272-0780

K974014 Re : Pulpdent Dentastic Uno Trade Name: Regulatory Class: II Product Code: EMA Dated: October 15, 1997 October 22, 1997 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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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. A 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 requlation (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

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Page 2 - Mr. Berk

not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fpa.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Ulatowski 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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974014 510(k) Number (if known): Device Name: Den TASTIC UND

Indications For Use:

Pulpdent DenTASTIC UNO is a single component dental adhesive primer and bond enhancer used by the dental professional to bond to dentin, enamel, metals and resins.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runnes

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

Prescription Use (Per 21 CFR 801. 109)

Over-The-Counter Use No

ter Use No

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.