(17 days)
No
The summary describes a dental resin system for fabricating appliances, with no mention of AI, ML, image processing, or any computational analysis that would typically involve these technologies.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is used for the fabrication and repair of "prescription therapeutic dental appliances" to mitigate damage from parafunctional dental habits.
No
This device is a dental resin system used for fabricating or repairing therapeutic dental appliances like occlusal guards, which are used to mitigate damage from parafunctional habits (e.g., bruxism). It is a material for treatment, not a device for diagnosing a condition.
No
The device description explicitly states it includes "visible light cured materials in arch form," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication and repair of dental appliances used to mitigate damage from parafunctional habits. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a visible light cured resin system for creating dental appliances. This is a material used in a therapeutic process, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the ION Dental Resin System falls under the category of a dental material used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes
EBI and MQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ION Dental Resin System has been evaluated and passed biocompatibility testing for cytoxicity, mutagenicity, dermal sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Trubyte Denture Base Resin System (K032892)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.
0
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
Image /page/0/Picture/13 description: The image shows a sequence of numbers. The numbers are all zeros except for a one in the fifth position and a zero in the sixth position. The sequence of numbers is 000010.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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.
2
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
3
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