ASD Oral Appliances

K163580 · American Sleep Dentistry · LRK · Jun 8, 2017 · Dental

Device Facts

• Record ID: K163580
• Device Name: ASD Oral Appliances
• Applicant: American Sleep Dentistry
• Product Code: LRK · Dental
• Decision Date: Jun 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Device Story

ASD Oral Appliances comprise five patient-specific, removable intraoral models (Anterior, Mezzo, Lateral, Elastic, Lateral Mezzo) designed to reposition the mandible forward. This mechanical action prevents soft tissue of the throat from collapsing and obstructing the airway, thereby reducing snoring and mild-to-moderate OSA. Devices are fabricated from thermoformed polymers (copolyester, EVA) and stainless steel or latex-free polymer components. A clinician fits the device to the patient's anatomy; the patient then uses the device at home during sleep. The device requires no energy source. By maintaining a forward mandibular position, the appliance helps maintain airway patency, potentially benefiting patients by alleviating sleep-disordered breathing symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on descriptive characteristics and technological comparison to legally marketed predicate devices.

Technological Characteristics

Intraoral mandibular repositioning device. Materials: thermoformed polymers (copolyester, EVA) and stainless steel or latex-free polymer connectors. Form factor: patient-specific upper and lower trays. Mechanism: hook and base or elastic band/strap systems. Non-sterile; cleaned by patient. No energy source. No software or algorithm.

Indications for Use

Indicated for reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Predicate Devices

• American Sleep Association (ASA) Oral Appliances (K130504)

Reference Devices

• Removable Acrylic Herbst (K070327)
• TAP III (K062951)
• EMA (K971794)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 8, 2017

American Sleep Dentistry Ryan Gregerson President 1957 West Royal Hunte Drive Ste 250 Cedar City, Utah 84720-1903

Re: K163580

Trade/Device Name: ASD Oral Appliances Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: May 5, 2017 Received: May 9, 2017

Dear Ryan Gregerson:

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. 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

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -A

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K163580

Device Name

American Sleep Dentistry (ASD) Oral Appliances

Indications for Use (Describe)

The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

| 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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## K163580 510(k) Summary

| Date: | May 31, 2017 |
|------------------------|------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | American Sleep Dentistry, LLC<br>1957 West Royal Hunte Dr, Ste 250<br>Cedar City, UT 84720-1903<br>Phone: [phone] |
| Contact Person: | Ryan Gregerson, Manager |
| Trade Names: | American Sleep Dentistry (ASD) Oral Appliances |
| Device Classification: | Class II |
| Classification Name: | Device, Anti-Snoring and device, jaw repositioning |
| Regulation: | 21 CFR 872.5570, Intraoral devices for snoring and<br>intraoral devices for snoring and obstructive sleep apnea |
| Device Product Code: | LRK |

Device Description: The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.

The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.

Intended Use: The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate Obstructive Sleep Apnea (OSA) in individuals 18 years of age or older.

### Primary Predicate Device:

American Sleep Association (ASA) Oral Appliances (K130504)

### Reference Predicate Devices:

Removable Acrylic Herbst (K070327) TAP III (K062951) EMA (K971794)

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### Technological Characteristics:

The ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances possess the same technological characteristics as one or more of the predicate devices.

These include:

- . Anatomic location (intraoral),
- Intended Use, to treat mild to moderate sleep apnea.
- Basic design (mandibular repositioning using upper and lower polymer trays with a . hook and base mechanism),
- . Principles of Operation
- . Materials (polymer and/or stainless steel), and
- Manufacture (appliance is patient specific fabricated by prescription to the specific ● requirements of a single patient).

The ASD Anterior model and predicate device, Tap III are both patient specific made Oral Appliances that include a hook and base mechanism placed on the anterior of the front teeth. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Lateral model and predicate device Tap III are both patient specific made Oral Appliances that include a hook and base mechanism and is located the same as the TAP III, but the ASD Lateral model adds the additional anchors to the canine teeth for advanced stability. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Lateral Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism. The ASD Lateral Mezzo hook and base mechanism is like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differ slightly, but no new or different questions of safety and efficacy are raised by the differences.

The ASD Elastic model and predicate device EMA are both patient specific made Oral Appliances that include varying lengths of elastic bands or straps and are both placed bilaterally. The ASD Elastic, however anchors the straps in by stainless steel, while the EMA uses plastic anchors. The actual material differs slightly, but no new or different questions of safety and efficacy are raised by the differences.

The fundamental scientific technology of the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances is the same as previously cleared devices.

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| Substantial<br>Equivalence<br>Comparison<br>Features | ASD<br>Anterior,<br>ASD Mezzo,<br>ASD Lateral,<br>ASD Elastic<br>and ASD<br>Lateral<br>Mezzo | ASA Oral<br>Appliances<br>[Primary<br>Predicate] | Removable<br>Acrylic<br>Herbst<br>[Reference<br>Predicate] | Tap III<br>[Reference<br>Predicate] | EMA<br>[Reference<br>Predicate] |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Intended<br>use/<br>Indications<br>for use: | Intended for<br>the reduction<br>of nighttime<br>snoring and<br>mild to<br>moderate<br>obstructive<br>sleep apnea<br>(OSA) in<br>individuals 18<br>years of age<br>or older. | Intended for<br>the reduction<br>of nighttime<br>snoring and<br>mild to<br>moderate<br>obstructive<br>sleep apnea<br>(OSA) in<br>individuals 18<br>years of age<br>or older. | Intended for<br>the reduction<br>of snoring<br>and mild to<br>moderate<br>obstructive<br>sleep apnea<br>(OSA) by<br>moving the<br>lower jaw into<br>a prescribed<br>relationship<br>to the upper<br>jaw. | Intended to<br>reduce or<br>alleviate<br>nighttime<br>snoring and<br>mild to<br>moderate<br>obstructive<br>sleep apnea,<br>OSA. | Treatment of<br>nasal<br>respiratory<br>dysfunction of<br>obstructive<br>sleep apnea<br>and snoring<br>in those<br>patients<br>where<br>repositioning<br>of the<br>mandible can<br>increase the<br>patient's air<br>space |
| Prescription/<br>OTC Use | Prescription | Prescription | Prescription | Prescription | Prescription |
| Principle of<br>Operation | Once fitted<br>to the patient,<br>the device<br>positions the<br>lower jaw<br>forward,<br>preventing<br>soft tissue of<br>the throat<br>from<br>collapsing<br>and<br>obstructing<br>the airway,<br>therefore<br>alleviating or<br>reducing the<br>symptoms of<br>nighttime<br>snoring and<br>mild to<br>moderate | Once fitted to<br>the patient,<br>the device<br>positions the<br>lower jaw<br>forward,<br>preventing<br>soft tissue of<br>the throat<br>from<br>collapsing<br>and<br>obstructing<br>the airway,<br>therefore<br>alleviating or<br>reducing the<br>symptoms of<br>nighttime<br>snoring and<br>mild to<br>moderate | Once fitted to<br>the patient,<br>the device<br>positions the<br>lower jaw<br>forward,<br>preventing<br>soft tissue of<br>the throat<br>from<br>collapsing<br>and<br>obstructing<br>the airway,<br>therefore<br>alleviating or<br>reducing the<br>symptoms of<br>nighttime<br>snoring and<br>mild to<br>moderate | Once fitted to<br>the patient,<br>the device<br>positions the<br>lower jaw<br>forward,<br>preventing<br>soft tissue of<br>the throat<br>from<br>collapsing<br>and<br>obstructing<br>the airway,<br>therefore<br>alleviating or<br>reducing the<br>symptoms of<br>nighttime<br>snoring and<br>mild to<br>moderate | Once fitted to<br>the patient,<br>the device<br>positions the<br>lower jaw<br>forward,<br>preventing<br>soft tissue of<br>the throat<br>from<br>collapsing<br>and<br>obstructing<br>the airway,<br>therefore<br>alleviating or<br>reducing the<br>symptoms of<br>nighttime<br>snoring and<br>mild to<br>moderate |
| American Sleep Dentistry, LLC<br>ASD Oral Appliances<br>Traditional Premarket Notification [510(k)]<br>May 2017 | | | | | |
| Substantial<br>Equivalence<br>Comparison<br>Features | ASD<br>Anterior,<br>ASD Mezzo,<br>ASD Lateral,<br>ASD Elastic<br>and ASD<br>Lateral<br>Mezzo | ASA Oral<br>Appliances<br>[Primary<br>Predicate] | Removable<br>Acrylic<br>Herbst<br>[Reference<br>Predicate] | Tap III<br>[Reference<br>Predicate] | EMA<br>[Reference<br>Predicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| | Obstructive<br>Sleep Apnea<br>(OSA). | Obstructive<br>Sleep Apnea<br>(OSA). | Obstructive<br>Sleep Apnea<br>(OSA). | Obstructive<br>Sleep Apnea<br>(OSA). | Obstructive<br>Sleep Apnea<br>(OSA). |
| Design:<br>ASD<br>Anterior | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with hook and<br>base<br>mechanism<br>placed on the<br>anterior of the<br>front teeth. | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms<br>with bilateral,<br>reclosable,<br>polymer<br>fasteners or<br>both | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms | Mandibular<br>repositioner<br>having upper<br>and lower<br>trays with a<br>Hook and<br>Base<br>mechanism<br>placed on the<br>anterior of the<br>front teeth. | |
| Design:<br>ASD Mezzo | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with a hook<br>and base<br>mechanism<br>placed<br>bilaterally | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms<br>with bilateral,<br>reclosable,<br>polymer<br>fasteners or<br>both | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms | Mandibular<br>repositioner<br>having upper<br>and lower<br>trays with a<br>Hook and<br>Base<br>mechanism<br>placed on the<br>anterior of the<br>front teeth. | |
| American Sleep Dentistry, LLC | | | Traditional Premarket Notification [510(k)] | | |
| ASD Oral Appliances | | | May 2017 | | |
| Substantial<br>Equivalence<br>Comparison<br>Features | ASD<br>Anterior,<br>ASD Mezzo,<br>ASD Lateral,<br>ASD Elastic<br>and ASD<br>Lateral<br>Mezzo | ASA Oral<br>Appliances<br>[Primary<br>Predicate] | Removable<br>Acrylic<br>Herbst<br>[Reference<br>Predicate] | Tap III<br>[Reference<br>Predicate] | EMA<br>[Reference<br>Predicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Design:<br>ASD Lateral | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with hook and<br>base<br>mechanism<br>placed on the<br>anterior of the<br>teeth. With<br>anchors<br>placed on the<br>canine teeth. | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms<br>with bilateral,<br>reclosable,<br>polymer<br>fasteners or<br>both | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms | Mandibular<br>repositioner<br>having upper<br>and lower<br>trays with a<br>Hook and<br>Base<br>mechanism<br>placed on the<br>anterior of the<br>front teeth. | |
| Design:<br>ASD Lateral<br>Mezzo | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with a hook<br>and base<br>mechanism<br>placed<br>bilaterally | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms<br>with bilateral,<br>reclosable,<br>polymer<br>fasteners or<br>both | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>with bilateral<br>Herbst<br>mechanisms | Mandibular<br>repositioner<br>having upper<br>and lower<br>trays with a<br>Hook and<br>Base<br>mechanism<br>placed on the<br>anterior of the<br>front teeth. | |
| | | | | | |
| ASD Oral Appliances<br>May 2017 | | | | | |
| Substantial<br>Equivalence<br>Comparison<br>Features | ASD<br>Anterior,<br>ASD Mezzo,<br>ASD Lateral,<br>ASD Elastic<br>and ASD<br>Lateral<br>Mezzo | ASA Oral<br>Appliances<br>[Primary<br>Predicate] | Removable<br>Acrylic<br>Herbst<br>[Reference<br>Predicate] | Tap III<br>[Reference<br>Predicate] | EMA<br>[Reference<br>Predicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Design:<br>ASD Elastic | Mandibular<br>repositioner<br>having upper<br>and lower<br>polymer trays<br>and elastic<br>bands or<br>straps with<br>stainless<br>steel<br>anchors. | | | | Mandibular<br>repositioner<br>having upper<br>and lower<br>trays with<br>bilateral<br>elastic bands<br>or straps with<br>plastic<br>anchors. |
| Materials:<br>ASD<br>Anterior<br>ASD Mezzo<br>ASD Lateral<br>ASD Lateral<br>Mezzo | | | | | |
| Polymer<br>Splint | | PETG/TPU,<br>EVA | Acrylic | Acrylic | |
| Connecting<br>Mechanism | | 303/304<br>Stainless<br>Steel | 303/304<br>Stainless<br>Steel | 303/304<br>Stainless<br>Steel | |
| Materials:<br>ASD Elastic | | | | | |
| Polymer<br>Splint | PETG/TPU,<br>EVA | | | | Acrylic |
| Connecting<br>Mechanism | Latex free<br>Polymer | | | | Latex free<br>Polymer |
| eep Dentistry, LLC | | Traditional Premarket Notification [510(k)] | | | |
| Opliances | | | | May 2017 | |
| ASD<br>Anterior,<br>ASD Mezzo,<br>ASD Lateral,<br>ASD Elastic<br>and ASD<br>Lateral<br>Mezzo | ASA Oral<br>Appliances<br>[Primary<br>Predicate] | Removable<br>Acrylic<br>Herbst<br>[Reference<br>Predicate] | Tap III<br>[Reference<br>Predicate] | EMA<br>[Reference<br>Predicate] | |
| K163580 | K130504 | K070327 | K062951 | K971794 | |
| | | | | | |
| Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm | |
| Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive | |

# B. Substantial Equivalence Comparison Table:

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Traditional Premarket Notification [510(k)]

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Traditional Premarket Notification [510(k)]

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American Sleep ASD Oral Applia

Substantial

Equivalence
Comparison
Features

510k #

| Range and<br>precision of<br>adjustment | Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm | Front to back<br>+/- 1 mm |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target<br>Population | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive<br>Sleep Apnea | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive<br>Sleep Apnea | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive<br>Sleep Apnea | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive<br>Sleep Apnea | Patients<br>diagnosed<br>with mild to<br>moderate<br>Obstructive<br>Sleep Apnea |
| Where Used: | Fitted by a<br>clinician,<br>used at<br>home. | Fitted by a<br>clinician,<br>used at<br>home. | Fitted by a<br>clinician,<br>used at<br>home. | Fitted by a<br>clinician,<br>used at<br>home. | Fitted by a<br>clinician,<br>used at<br>home. |
| Energy<br>Used/<br>Delivered: | None | None | None | None | None |
| Human<br>Factors: | The device is<br>fitted by the<br>dentist. The<br>patient is<br>instructed in<br>its use and<br>care.<br>Subsequent<br>use by the<br>patient is as<br>directed by<br>the dentist in<br>accordance<br>with the<br>provided<br>instructions<br>for use. | The device is<br>fitted by the<br>dentist. The<br>patient is<br>instructed in<br>its use and<br>care.<br>Subsequent<br>use by the<br>patient is as<br>directed by<br>the dentist in<br>accordance<br>with the<br>provided<br>instructions<br>for use. | The device is<br>fitted by the<br>dentist. The<br>patient is<br>instructed in<br>its use and<br>care.<br>Subsequent<br>use by the<br>patient is as<br>directed by<br>the dentist in<br>accordance<br>with the<br>provided<br>instructions<br>for use. | The device is<br>fitted by the<br>dentist. The<br>patient is<br>instructed in<br>its use and<br>care.<br>Subsequent<br>use by the<br>patient is as<br>directed by<br>the dentist in<br>accordance<br>with the<br>provided<br>instructions<br>for use. | The device is<br>fitted by the<br>dentist. The<br>patient is<br>instructed in<br>its use and<br>care.<br>Subsequent<br>use by the<br>patient is as<br>directed by<br>the dentist in<br>accordance<br>with the<br>provided<br>instructions<br>for use. |
| | | | | | |

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