PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM

K982394 · Dentsply Intl. · KLE · Sep 21, 1998 · Dental

Device Facts

• Record ID: K982394
• Device Name: PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
• Applicant: Dentsply Intl.
• Product Code: KLE · Dental
• Decision Date: Sep 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM is used for Direct composite and compomer restorations; Composite, ceramic and amalgam repairs; Cavity varnish for use with fresh amalgam; Indirect restorations-dual cure, inlays, onlays, veneers, crowns and bridges; Endodontic post cementation; and Adhesive bonding of direct amalgam restorations.

Device Story

Prime & Bond NT Dual Cure Universal Dental Adhesive System is a one-component, no-mix, visible light-curable dental bonding agent containing fluoride. Used by dental professionals in clinical settings for restorative procedures. When combined with the provided activator, the agent supports self-cure or dual-cure polymerization. The system facilitates bonding for direct restorations, repairs, and indirect restorations. It functions as a chemical adhesive interface between tooth structure and restorative materials. Benefits include versatility across multiple dental applications and compatibility with various restorative materials.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity/growth inhibition) performed on the cured bonding agent demonstrated acceptable results. No clinical data provided.

Technological Characteristics

One-component, no-mix, visible light-curable dental adhesive containing fluoride. Dual-cure capability achieved via addition of an activator. Components are established in legally marketed dental devices. Biocompatibility confirmed via cytotoxicity testing.

Indications for Use

Indicated for dental patients requiring direct composite/compomer restorations, composite/ceramic/amalgam repairs, cavity varnish for fresh amalgam, indirect restorations (inlays, onlays, veneers, crowns, bridges), endodontic post cementation, and adhesive bonding of direct amalgam restorations.

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

• Prime & Bond® 2.1 Dual Cure Universal Dental Adhesive System (K962348, K964525)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 21 1998

DENTSPLY

## 510(k) SUMMARY

NAME & ADDRESS:

Ka982394

DENTSPLY International

570 West College Avenue O. Box 872 York, PA 17405-0872 171 845-7511 77 051 2212

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

DATE PREPARED: JUL 0 8 1998

TRADE OR PROPRIETARY NAME:

PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM

872.3200 Resin tooth bonding agent CLASSIFICATION NAME:

PREDICATE DEVICES:

Prime & Bond® 2.1 Dual Cure Universal Dental Adhesive System

K962348, K964525

000015

DEVICE DESCRIPTION: PRIME & BOND® NT™ BONDING AGENT is a one-component, no-mix visible light-curable dental bonding agent that contains fluoride. When used with the activator provided (K964525), the bonding agent may be self-cured or dual-cured.

The physical properties of PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM are comparable to Prime & Bond® 2.1 Bonding Agent (K962348).

INTENDED USE: PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM is used for Direct composite and compomer restorations; Composite, ceramic and amalgam repairs; Cavity varnish for use with fresh amalgam; Indirect restorations-dual cure, inlays, onlays, veneers, crowns and bridges; Endodontic post cementation; and Adhesive bonding of direct amalgam restorations.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM have either been used in predicate dental devices or have been found safe for dental use.

PRIME & BOND® NT™ BONDING AGENT (cured material) was tested for cytotoxicity (growth inhibition test) and found to be acceptable.

We believe that the prior use of the components of PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM in legally marketed predicate devices, the performance data, and the results of biocompatibility testing support the safety and effectiveness of PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM for the indicated uses.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design resembling an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the top of the seal. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 1998

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re : K982394 Trade Name: Prime & Bond® NT™ Dual Cure Universal Dental Adhesive System Regulatory Class: II Product Code: KLE ....... Dated: July 8, 1998 Received: July 9, 1998

Dear Mr. Lehn:

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 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 (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. ਚ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 ... . 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Paqe 2 - Mr. Lehn

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 [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" (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.fda.gov/cdrh/dsmamain:html".

Sincerely yours,

Susan Runser

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

Enclosure

{3}------------------------------------------------

## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

K982394

Device Name: PRIME & BOND® NT™ DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM

- · Direct composite and compomer restorations
- · Composite, ceramic and amalgam repairs
- · Cavity varnish for use with fresh amalgam
- · Indirect restorations: Dual Cure, inlays, onlays, veneers, crowns and bridges
- · Endodontic post cementation
- · Adhesive bonding of direct amalgam restorations

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

OR

Over-The-Counter Use

Susan Purser

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982394

000007