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DE1093: IC Tip of the Week: I was told that my dental instruments need to be FDA cleared. How do I know?
This is based upon the tip of the week e-mail sent out by DOH the week of September 23rd, 2025. To gain CDE credit, participants must successfully pass a test [score 80] based upon the reading material.
Reading Materials:
How to Determine if a Product is a Medical Device: https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
Overview of Device Regulation: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
510[k] Premarket Notification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
Dental Product Classification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&submission_type_id=&devicename=&productcode=&deviceclass=&thirdparty=&panel=de®ulationnumber=&pagenum=500&sortcolumn=devicename
Classify Your Medical Device: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
Class I/II Exemptions: https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-ii-exemptions
The FDA States:
In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic [IVD] products, such as reagents, test kits, and blood glucose meters. Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.
Device Determination Steps
The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device.
• Step 1: Determine if your product meets the definition of a medical device per Section 201[h] of the Food, Drug & Cosmetic Act.
• Step 2: Determine if an appropriate product classification exists for your product
Upon reviewing the NIPCS Tip of the week, you will:
1. Understand the importance of regulatory entities
2. Recognize Dental Product Classification
3. Understand who regulates dental equipment
Damon Pope — Deputy Project Manager for the IHS Electronic Dental Record IHS DOH National Infection Control Consultant For follow-up questions, please contact the speaker at damon.pope@ihs.gov.
The speaker has no conflicts of interest to report.
It is the policy of the Indian Health Service, Division of Oral Health, that faculty/planners disclose any financial or other relationships with commercial companies whose products may be discussed in the educational activity. The Indian Health Service, Division of Oral Health, also requires that faculty disclose any unlabeled or investigative use of pharmaceutical products and medical devices. Images that have been falsified or manipulated to misrepresent treatment outcomes are prohibited.
None of the faculty/planners for this activity has a conflict of interest, and there is no use of unlabeled or investigative pharmaceutical products or medical devices. No images have been falsified or manipulated to misrepresent treatment outcomes.The educational objectives, content, and selection of educational methods and instructors are conducted independent of any commercial entity.
The IHS Division of Oral Health is an accredited sponsor of continuing education under the American Dental Association Continuing Education Recognition Program (CERP). ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the IHS at IHS CDE Coordinator or to the Commission for Continuing Education Provider Recognition at CCEPR.ada.org
Please Make Checks Payable to: Indian Health Service.
Tuition must be paid in full 8 weeks prior to the start date of any course. Request for refunds must be received in writing at least two weeks before the course begins. For each refund request, there will be an administrative charge of $100. No refunds will be made to registrants who fail to attend a course. If IHS CDE program cancels a course, then 100% of the tuition will be refunded.
