(17 days)
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).
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.
The provided text is related to a 510(k) submission for the "ION Dental Resin System." This device is a dental material used for fabricating therapeutic interdental appliances. The information provided heavily focuses on regulatory aspects, intended use, and substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria.
Therefore, many of the requested sections about acceptance criteria and study details cannot be fully answered or are not applicable based on the provided text. The document is a 510(k) summary, which typically focuses on showing substantial equivalence rather than presenting extensive performance study data in the way a clinical trial for a diagnostic AI device would.
Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported performance metrics are not explicitly stated. The submission emphasizes substantial equivalence and biocompatibility.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit for performance | "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." |
| Biocompatibility | "ION Dental Resin System has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, dermal sensitization." |
| Substantial Equivalence to K032892 | "The ION Dental Resin System represents a modification to K032892." "We believe that the prior use of the components... the performance data provided, and the biocompatibility data provided support the safety and effectiveness... " |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. The submission references "performance data provided" but does not detail the specifics of any test set used, its size, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The device is a dental resin system, not a diagnostic imaging device that would typically involve expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text. As noted, the submission does not detail a test set requiring adjudication in this manner.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This device is a material for fabricating dental appliances, not an AI-powered diagnostic tool, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or described in the provided context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a material, not an algorithm, so a standalone performance study in this context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility testing, the "ground truth" would be established by standard accredited laboratory testing methods and interpretation of results against established safety thresholds for cytotoxicity, mutagenicity, and dermal sensitization. Details of these standards are not provided in the text. For the overall performance, the "ground truth" is implied by the safety and performance of the predicate device (K032892) and the proven safety of its components.
8. The sample size for the training set
This information is not provided in the text. The concept of a "training set" as it applies to machine learning algorithms is not relevant to this device.
9. How the ground truth for the training set was established
Not Applicable. As above, the concept of a "training set" and its ground truth is not applicable to this type of medical device (dental resin).
{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
§ 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.