The POD

K182820 · Advanced Facialdontics, LLC · MQC · Jul 17, 2019 · DE

Device Facts

• Record ID: K182820
• Device Name: The POD
• Applicant: Advanced Facialdontics, LLC
• Product Code: MQC · DE
• Decision Date: Jul 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

The POD® is a prescription-only, removable, custom-fabricated dental mouthguard worn on the mandibular arch during sleep. A dentist obtains a dental impression and prescribes the design; the device is then laboratory-fabricated and delivered to the patient for home use. The device functions via disocclusion, which protects teeth and restorations while reducing symptoms of pain and headaches associated with clenching and bruxing. It is constructed from Polymethyl methacrylate (PMMA) and medical-grade stainless steel wire. The device is non-sterile and intended for limited duration contact (<24 hours) with skin and mucosal membranes.

Clinical Evidence

No clinical data. Bench testing only. Physical properties (flexural strength, modulus, fracture toughness, water sorption/solubility, residual monomer) met ISO 20795-2:2013 criteria. Biocompatibility testing (cytotoxicity, sensitization, mucosal irritation) met ISO 10993-5 and ISO 10993-10 criteria. Risk analysis performed per ISO 14971.

Technological Characteristics

Custom-fabricated mandibular mouthguard. Materials: Polymethyl methacrylate (PMMA) and medical-grade stainless steel wire. Principle: Disocclusion. No external energy, software, or EMR. Provided non-sterile. Complies with ISO 20795-2:2013 for orthodontic base polymers.

Indications for Use

Indicated for the amelioration of clenching and bruxing associated with TMD and to aid in the relief of symptoms of TMD/TMJ in patients requiring a prescription dental mouthguard.

Predicate Devices

• Urbanek Device (K170985)

Reference Devices

• Luco Hybrid OSA Appliance (K160477)
• NTI Clenching Suppression System (K981546)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
|------------------------------------------------------------------------------------------------|---------------------------------------------|

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Image /page/3/Picture/1 description: The image shows the logo for Advanced Facialdontics. The logo consists of a stylized DNA helix symbol to the left of the text "Advanced Facialdontics" in a bold, sans-serif font. A registered trademark symbol is present to the right of the text.

# 510(k) Summary

# 1. Owner Information

| Owner's Name: | Advanced Facialdontics LLC |
|------------------|----------------------------------------------|
| Owner's Address: | 325 Lake Ave, Unit 759<br>St James, NY 11780 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Dr Scott Simonetti |
| Email: | [e-mail] |
| 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.

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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 (<24 h) contact of the skin and of mucosal membranes.

The subject device provides a disocclusion that protects the teeth and restorations while helping to reduce symptoms of pain and headaches.

- 5. Indications for Use: The POD® is for the amelioration of clenching and bruxing associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
## 6. Comparison to Predicate Device

Technological Characteristics: The predicate and the subject device have the exact same following technological characteristics:

- Principle of Operation
- Indications of Use
- Prescription Device
- Custom fabricated
- Environment of Use: Home
- Removable by patient and reusable
- Provided Non-sterile
- No external energy, software or EMR
- Medical grade stainless steel

The following technological differences exist between the subject device and predicate device:

- Specific Type of acrylic used
- Location the device sits within the oral cavity
- Location of disocclusion mechanism

The Indications of Use statement is identical, the intended use of the devices are the same and the fundamental scientific technology of the subject device is the same as the previously cleared predicate and reference devices as shown in Table 1. Each previously cleared device utilizes a slightly different design to perform the same intended use.

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| | | | Table 1: Comparison of Subject, Predicate and Reference Devices |
|--|--|--|-----------------------------------------------------------------|
|--|--|--|-----------------------------------------------------------------|

| | Subject Device | Primary Predicate | Reference Device | Reference Device |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | The POD®<br>K182820 | Urbanek Device<br>K170985 | Luco Hybrid OSA<br>Appliance<br>K160477 | NTI Clenching<br>Suppression System<br>K981546 |
| Product<br>Code | MQC, OCO | MQC, OCO | MQC, OCO | MQC, OCO |
| Indications<br>for Use | The POD® is for the<br>amelioration of<br>clenching and<br>bruxing associated<br>with TMD and is to<br>be used to aid in<br>the relief of<br>symptoms of<br>TMD/TMJ. | The Urbanek Device<br>is for the<br>amelioration of<br>clenching and<br>bruxing associated<br>with TMD and is to<br>be used to aid in<br>the relief of<br>symptoms of<br>TMD/TMJ. | 1. A device to be<br>used for the<br>treatment of sleep<br>bruxism and<br>2. As an aid in the<br>treatment of<br>associated<br>tension/migraine<br>type headaches in<br>adults. | For the prevention of<br>chronic tension and<br>temporal mandibular<br>joint syndrome that is<br>caused by chronic<br>clenching of the<br>posterior mandibular<br>and maxillary teeth by<br>the temporalis muscle.<br>The device is custom<br>made for the individual. |
| Design<br>Features | Prescription Device<br>Custom fit | Same | Same | Same |
| | Intraoral Device | Same | Same | Same |
| | Provided Non-sterile | Same | Same | Same |
| | Removable by<br>patient and<br>reusable | Same | Same | Same |
| Environment<br>of Use | Home | Same | Same | Same |
| Principle of<br>Operation | Disocclusion | Disocclusion | Disocclusion | Disocclusion |
| Location of<br>Device | Mandibular arch | Maxillary arch | Mandibular and<br>Maxillary arch | Central Incisors |
| Disocclusion<br>Mechanism<br>Location | 1st molar and 2nd<br>Premolar | Canines and<br>Incisors | 1st Premolars | Central Incisors |
| Materials | Methyl<br>methacrylate,<br>medical grade<br>stainless steel | Thermoplastic<br>acrylic resin,<br>medical grade<br>stainless steel | Methyl<br>methacrylate,<br>chrome cobalt,<br>medical grade<br>stainless steel | Thermoplastic acrylic<br>resin |

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# 7. Non-Clinical Tests Performed

Bench Testing: The submission includes test data regarding the physical properties of the subject device including flexural strength, flexural modulus, maximum stress intensity factor, fracture toughness, water sorption, water solubility, and residual monomer. The physical properties comply with the pre-defined pass/fail criteria listed in the Recognized Standard ISO 20795-2:2013 Dentistry - Base Polymers - Part 2: Orthodontic Base Polymers, without any deviations, modifications or exclusions.

Biocompatibility Testing: Biocompatibility testing was conducted in accordance with the FDA guidance document "Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The submission includes full test reports regarding Cytotoxicity, Sensitization, and Mucosal Irritation according to ISO 10993-5 and ISO 10993-10. The subject device meets the predetermined pass/fail criteria.

In addition, a risk analysis was performed as per ISO 14971 and found no new concerns for the subject device.

## 8. Clinical Tests Performed

Clinical testing has not been performed.

#### 9. Conclusion

Based upon the comparative analysis of features, materials and design, the subject device has the same intended use, similar technological characteristics and the same mechanism of action as the predicate device. Performance data shows that the subject device meets the requirements specified in the applicable standards. It is concluded that The POD® is substantially equivalent to the previously cleared device.