XENO NM LIGHT CURED DENTAL ADHESIVE

K041343 · Dentsply International · KLE · Jun 16, 2004 · Dental

Device Facts

• Record ID: K041343
• Device Name: XENO NM LIGHT CURED DENTAL ADHESIVE
• Applicant: Dentsply International
• Product Code: KLE · Dental
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Direct composite and compomer restorations for all cavity classes in anterior and posterior teeth. Veneers. Composite, ceramic and metal repairs. Cavity varnish for use with fresh amalgam.

Device Story

XENO® NM Light Cured Dental Adhesive is a one-component, light-cured, self-etching, and self-priming dental adhesive. It integrates acid etching, priming, and bonding into a single bottle. Used by dental professionals in clinical settings, it facilitates the bonding of composite materials and compomers to enamel and dentin, as well as repairs to metals and ceramics. The adhesive is applied to the tooth structure or restoration surface, then light-cured to create a bond. This simplifies the restorative workflow for the clinician, potentially improving efficiency and clinical outcomes for patients requiring dental restorations or repairs.

Clinical Evidence

Bench testing only. Biocompatibility evaluation including genotoxicity, cytotoxicity, and sensitivity testing was performed and found acceptable.

Technological Characteristics

One-component, light-cured, self-etching, self-priming dental adhesive. Contains components previously used in legally marketed dental devices. Biocompatible formulation.

Indications for Use

Indicated for direct composite and compomer restorations in anterior and posterior teeth, veneers, composite/ceramic/metal repairs, and as a cavity varnish for fresh amalgam. No specific age or gender restrictions provided.

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® NT™ Nano-Technology Light Cured Dental Adhesive (K982394)

Submission Summary (Full Text)

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# 1041343

# 510(k) SUMMARY

## JUN 1 6 2004

DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, PA 17405-0872 P. J. Lehn Telefax [phone]

XENO® NM Light Cured Dental Adhesive

P. Jeffery Lehn CONTACT:

May 17, 2004 DATE PREPARED:

TRADE OR PROPRIETARY NAME:

Resin tooth bonding agent (872.3200) CLASSIFICATION NAME:

Prime & Bond® NT™ Nano-Technology Light Cured PREDICATE DEVICES: K982394 Dental Adhesive

#### DEVICE DESCRIPTION:

The XENO® NM Light Cured Dental Adhesive is a one-component light cure self-etching and self-priming dental adhesive designed to bond composite materials and compomers to enamel and dentin as well as to metals and ceramic.

XENO® NM Light Cured Dental Adhesive combines acid etching, priming and adhesive in a single bottle.

INTENDED USE:

- Direct composite and compomer restorations. .
- . Veneer
- Composite, ceramic and metal repairs. ●
- Cavity varnish for use with fresh amalgam .

TECHNOLOGICAL CHARACTERISTICS:

All of the components found in XENO® NM Light Cured Dental Adhesive have been used in legally marketed devices.

XENO® NM Light Cured Dental Adhesive final formulation was evaluated for biocompatibility for genotoxicity, cytotoxicity, and sensitivity and found acceptable.

We believe that the prior use of the components of XENO® NM Light Cured Dental Adhesive in legally marketed devices, the biocompatibility data provided, and the performance data provided support the safety and effectiveness of XENO® NM Light Cured Dental Adhesive for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 6 2004

Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404-0872

Re: K041343

Trade/Device Name: XENO® NM Light Cured Dental Adhesive Regulation Number: 872.3200 Regulation Name: Resin tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 17, 2004 Received: May 20, 2004

Dear Mr. Lehn:

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 referenced above and have acterinatiosure) 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 Amendinens, of to actived acosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confors providens of an 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 II your device is classified (bood additional controls. Existing major regulations affecting (1 Nr.), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in ther announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements mean that FDA nas made a decornmances wating administered by other Federal agencies. of the Act of ally I cucral statutes and regulations, but not limited to: registration You must colliply with an the Act b requirement 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gED (21 CFR Part 800); and and listing (21 CFR Purt 007), laceling (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality bjections (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) This letter will anow you to begin mailering your substantial equivalence of your device to a premarket notification. The PDF Intelligence and the 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), If you desire specific advice for your de at [phone]. Also, please note the regulation prease contact une Other or Somplians premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Diviser [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ke Muluy

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

| 510(K) Number (if known): | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| | |

XENO® NM Light Cured Dental Adhesive Device Name:

Indications for Use:

XENO® NM Light Cured Dental Adhesive is indicated for:

- Direct composite and compomer restorations for all cavity classes in anterior and posterior . teeth
- Veneers .
- Composite, ceramic and metal repairs ●
- Cavity varnish for use with fresh amalgam .

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rupp

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number: Kal 1343