ION DENTAL RESIN SYSTEM

K072713 · Dentsply International, Inc. · EBI · Oct 12, 2007 · Dental

Device Facts

• Record ID: K072713
• Device Name: ION DENTAL RESIN SYSTEM
• Applicant: Dentsply International, Inc.
• Product Code: EBI · Dental
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ION Dental Resin System is indicated for the fabrication and/or repair of prescription therapeutic dental appliances (e.g. occlusal guards) used to mitigate damage associated with parafunctional dental habits (e.g. bruxism).

Device Story

ION Dental Resin System consists of visible light-cured materials provided in arch form. Used by dental professionals for fabrication or repair of prescription therapeutic appliances, specifically occlusal guards or splints. These appliances are designed to mitigate dental damage caused by parafunctional habits like bruxism. The system utilizes components previously cleared for dental use, ensuring biocompatibility for oral applications.

Clinical Evidence

No clinical data. Biocompatibility testing for cytotoxicity, mutagenicity, and dermal sensitization was performed.

Technological Characteristics

Visible light-cured dental resin system in arch form. Components are biocompatible and have been used in legally marketed dental devices. No specific ASTM standards cited.

Indications for Use

Indicated for patients requiring prescription therapeutic dental appliances, such as occlusal guards, to mitigate damage from parafunctional dental habits like bruxism.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• Trubyte Denture Base Resin System (K032892)

Submission Summary (Full Text)

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K072713

## 510(k) SUMMARY

307 1 2 2007

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|---------------------------------------------|
| DATE PREPARED: | September 24, 2007 |
| TRADE OR PROPRIETARY NAME: | ION Dental Resin System |
| CLASSIFICATION NAME: | Mouthguard, MQC, Inclassified |
| PREDICATE DEVICES: | Trubyte Denture Base Resin System (K032892) |

DEVICE DESCRIPTION: The ION Dental Resin System includes visible light cured materials in arch form, intended for the fabrication of prescription therapeutic interdental appliances (such as occlusal guards or splints) used to mitigate damage associated with parafunctional dental habits.

INTENDED USE: ION Dental Resin System is indicated for the fabrication and/or repair of prescription therapeutic dental appliances (e.g. occlusal guards) used to mitigate damage associated with parafunctional dental habits (e.g. bruxism).

TECHNOLOGICAL CHARACTERISTICS: The ION Dental Resin System represents a modification to K032892.

All of the components found in ION Dental Resin System have been used in legally marketed devices and/or were found safe for dental use. ION Dental Resin System has been evaluated and passed biocompatibility testing for cytoxicity, mutagenicity, dermal sensitization.

We believe that the prior use of the components of ION Dental Resin System in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of ION Dental Resin System for the indicated uses.

ION Dental Resin System

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2007

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872

Re: K072713

Trade/Device Name: ION Dental Resin System Regulation Number; 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI and MQC Dated: September 24, 2007 Received: September 25, 2007

Dear Ms. Lewis:

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 indications for use stated in the enclosure) 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 the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Smitte y. Michui Orts.

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

11072713

510(k) Number (if known):

Device Name: ION Dental Resin System

Indications for Use:

ION Dental Resin System is indicated for the fabrication and/or repair of prescription therapeutic dental appliances (e.g. occlusal guards) used to mitigate damage associated with parafunctional dental habits (e.g. bruxism).

These are the same indications for use previously cleared for K032892.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Cuomo

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

510(k) Number: K072713