No
The device description and summary of performance studies indicate a physical, custom-fabricated dental mouthguard without any mention of AI or ML components.
Yes
The device is intended to ameliorate clenching associated with TMD and aid in the relief of symptoms of TMD/TMJ, which are therapeutic actions.
No
The device is described as ameliorating and relieving symptoms of TMD/TMJ and providing disocclusion and protection, which are therapeutic functions, not diagnostic ones. It does not mention identifying or characterizing a disease or condition.
No
The device description clearly states it is a removable dental mouthguard made of physical materials (PMMA and stainless steel wire) and requires fabrication and delivery by a clinician. It is a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The POD® is a physical device worn inside the mouth to treat symptoms of TMD/TMJ. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for the "amelioration of clenching associated with TMD" and "relief of symptoms of TMD/TMJ." This is a therapeutic or symptomatic relief function, not a diagnostic one.
- Device Description: The description clearly outlines a physical mouthguard fabricated for the mandibular arch.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, the POD® falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The POD® is for the amelioration of clenching associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
Product codes
MQC, OCO
Device Description
The POD® is a prescription only, removable dental mouthguard worn on the mandibular arch during sleep. The one-piece device is fabricated for the mandibular arch and can be customized for each patient based on the clinician prescription. The dentist obtains a dental impression, prescribes the design, and once laboratory fabricated, delivers the custom-made device at the dental office to be used in the home setting.
Materials: Polymethyl methacrylate (PMMA Acrylic Resin - Orthocryl®) and medical grade stainless steel wire. Only the PMMA has body contact as the SS wire is embedded within the PMMA and does not contact the body.
Duration and type of contact: Surface device with a limited duration (
N/A
0
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July 17, 2019
Advanced Facialdontics LLC Scott Simonetti President 325 Lake Ave. Unit 759 St. James, New York 11780
Re: K182820
Trade/Device Name: The POD® Regulatory Class: Unclassified Product Code: MQC Subsequent Product Code: OCO Dated: April 10, 2019 Received: April 18, 2019
Dear Scott Simonetti:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182820
Device Name The POD®
Indications for Use (Describe)
The POD® is for the amelioration of clenching associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | --------------------------------------------- |
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510(k) Summary
1. Owner Information
| Owner's Name: | Advanced Facialdontics LLC |
|---|---|
| Owner's Address: | 325 Lake Ave, Unit 759 |
| St James, NY 11780 | |
| Telephone: | (631) 379-3902 |
| Fax: | (631) 277-4849 |
| Contact Person: | Dr Scott Simonetti |
| Email: | ssimonettidds@yahoo.com |
| Date Prepared: | 7/15/2019 |
2. Device Name
| Trade Name: | The POD® |
|---|---|
| Common Name: | Mouthguard, Prescription |
| Classification: | Unclassified, Pre-Amendment |
| Product Code: | MQC |
| Subsequent Product Code: | OCO |
| Review Panel: | Dental |
| 510(k) Number: | K182820 |
3. Predicate Devices
| Primary Predicate: | Urbanek Device (K170985) |
|---|---|
| Reference Devices: | Luco Hybrid OSA Appliance (K160477) |
| NTI Clenching Suppression System (K981546) |
4. Device Description
The POD® is a prescription only, removable dental mouthguard worn on the mandibular arch during sleep. The one-piece device is fabricated for the mandibular arch and can be customized for each patient based on the clinician prescription. The dentist obtains a dental impression, prescribes the design, and once laboratory fabricated, delivers the custom-made device at the dental office to be used in the home setting.
4
Materials: Polymethyl methacrylate (PMMA Acrylic Resin - Orthocryl®) and medical grade stainless steel wire. Only the PMMA has body contact as the SS wire is embedded within the PMMA and does not contact the body.
Duration and type of contact: Surface device with a limited duration (