Silent Nite sl

K183270 · Prismatik Dentalcraft, Inc. · LRK · Jul 17, 2019 · Dental

Device Facts

• Record ID: K183270
• Device Name: Silent Nite sl
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: LRK · Dental
• Decision Date: Jul 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Silent Nite® sl is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. Silent Nite® sl is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

Device Story

Silent Nite® sl is a mandibular advancement device (MAD) for snoring and mild to moderate OSA. It consists of custom-fitted upper and lower trays connected by plastic straps. The device is worn during sleep; it holds the mandible in a protrusive position to increase nasopharyngeal and oropharyngeal volume, improving airflow. The dentist prescribes the degree of protrusion, adjusted by selecting connector lengths (21.0 mm to 26.0 mm). The device is fabricated via thermo-molding using a soft polyurethane inner layer and a hard polyester outer layer. It is used in home or sleep lab settings. The patient inserts and removes the device independently. By maintaining jaw protrusion, it prevents airway collapse, potentially reducing snoring and OSA symptoms.

Clinical Evidence

Bench testing only. Performance supported by testing including water sorption (ASTM D570), water solubility (ASTM D790), flexural strength/modulus (ASTM D790), fracture work (ISO 20795-1), yield/tensile strength (ASTM D638/D412), elongation at break (ASTM D638), and impact strength (ISO 179). Biocompatibility testing (cytotoxicity, irritation, sensitization) performed per ISO 10993-1.

Technological Characteristics

Mandibular advancement device; custom-fitted trays (soft polyurethane inner, hard polyester outer). Advancement via plastic connectors (6 lengths, 1mm increments). Non-sterile. Biocompatibility per ISO 10993-1. Bench testing per ASTM D570, D790, D638, D412, ISO 20795-1, ISO 179.

Indications for Use

Indicated for reduction of snoring and mild to moderate OSA in patients 18+ years. Contraindicated for patients with central sleep apnea, severe respiratory disorders, loose teeth, advanced periodontal disease, or TMJ dysfunction.

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

• OASYS Hinge Appliance™ (K083209)
• SilentNite® (K972424)

Submission Summary (Full Text)

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July 17, 2019

Prismatik Dentalcraft. Inc. Mythili Reguraman RA/QA Associate 2181 Dupont Dr. Irvine, California 92612

Re: K183270

Trade/Device Name: Silent Nite sl 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: June 14, 2018 Received: June 17, 2018

Dear Mythili Reguraman:

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.

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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); 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 Ouality Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color, including blue, green, yellow, orange, and pink. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

# 007_Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| | Form Approved: OMB No. 0910-0120 |
| | Expiration Date: 06/30/2020 |
| | See PRA Statement below. |
| 510(k) Number (if known) | K183270 |
| Device Name | Silent Nite® sl |
| Indications for Use (Describe) | Silent Nite® sl is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. Silent Nite® sl is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient. |
| Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 008_510(k) Summary

This 510(k) summary of substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

### SUBMITTER INFORMATION A.

B.

| Company Name: | Prismatik Dentalcraft, Inc. |
|-------------------------------|---------------------------------------------------------------------------------------------------|
| Company Address: | 2181 Dupont Dr.<br>Irvine, CA 92612 |
| Company Phone | [phone] |
| Company Fax | [phone] |
| Facility Registration Number: | 2031503 |
| Primary Contact Person: | Mythili Reguraman<br>RA/QA Associate |
| Date Summary Prepared: | June 4, 2019 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Silent Nite® sl |
| Common Name: | Anti-Snoring Device |
| Classification Name: | Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>apnea |
| Regulation Number: | 21 CFR 872.5570 |
| Product Code: | LRK |
| Device Class: | 2 |
| Review Panel: | Dental |

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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, ranging from pink to blue to yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.

#### IDENTIFICATION OF PREDICATE DEVICE C.

OASYS Hinge Appliance™ (K083209) Primary Predicate:

Reference Predicate Device: SilentNite® (K972424)

#### DEVICE DESCRIPTION D.

Silent Nite® sl is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older who prefer it to CPAP or surgical treatment, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP or surgical treatment. Silent Nite® sl holds the mandible in a protrusive position to increase the volume of the nasopharynx and the oropharynx and improves airflow during sleep. It is meant to be worn during sleep by a single patient. It consists of one upper tray, one lower tray, and two connectors and is provided non-sterile.

The trays are patient-specific and conform precisely to the patient's dentition. A biocompatible dual-layered heat sensitive impression material make up the upper and lower trays. The trays consist of a soft polyurethane inner layer that provides patient comfort and a durable hard polyester outer layer. A completely rigid polyester material is necessary for the fabrication of the lower tray when the patient has poor retention.

The maxillary tray is connected to a mandibular tray by two connectors of the same length. Each connector is fixed to the anterior of the maxillary tray and the posterior of the mandibular tray, on the respective right and left buccal sides. The amount of mandibular protrusion is adjusted by varying the length of the connectors. The shorter the connector the more anteriorization. Silent Nite® sl connectors are available in six different lengths (21.0 mm, 22.0 mm, 24.0 mm, 24.0 mm, 25.0 mm, and 26.0 mm) to allow the device to be adjusted up to 6.0 mm, in 1.0 mm increments.

#### E. INDICATIONS FOR USE

Silent Nite® sl is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. Silent Nite® sl is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

### F. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Refer to the Comparison Table below showing similarities and differences between the primary predicate device, reference predicate device, and subject device.

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side, which is filled with a gradient of colors. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the triangle. The text is in a sans-serif font and is blue.

### Table 1 – Comparison between Primary Predicate device, Reference Predicate device, and Subject device

| | Subject Device<br>Silent Nite® sl | Primary Predicate<br>Device<br>OASYS Hinge<br>ApplianceTM | Reference<br>Predicate<br>Device<br>SilentNite® | Comparison |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Trade Name | | | | |
| 510(k) | K183270 | K083209 | K972424 | |
| Regulatory<br>Classification | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | Same as Primary<br>and Reference<br>Predicate Devices |
| Product Code | LRK | LRK | LRK | Same as Primary<br>and Reference<br>Predicate Devices |
| Classification | II | II | Unclassified | Same as Primary<br>Predicate Device |
| Intended Use | Snore Prevention and<br>Treatment of Obstructive<br>Sleep Apnea | Snore Prevention and<br>Treatment of Obstructive<br>Sleep Apnea | Snore Prevention<br>and Treatment of<br>Obstructive Sleep<br>Apnea | Same as Primary<br>and Reference<br>Predicate Devices |
| Indications for<br>Use | To reduce snoring and<br>mild to moderate<br>obstructive sleep apnea<br>(OSA) in patients 18<br>years of age or older.<br>Silent Nite sl is worn<br>while sleeping to support<br>the lower jaw in a<br>forward position<br>prescribed by the dentist.<br>The appliance is<br>removable by the patient. | To reduce snoring and<br>mild to moderate<br>obstructive sleep apnea<br>(OSA) in patients 18<br>years of age or older.<br>The appliance is worn<br>while sleeping to support<br>the lower jaw in a<br>forward position<br>prescribed by the dentist.<br>The appliance is<br>removable by the patient. | Refer to Indications<br>for Use statement of<br>K972424. | Same as Primary<br>Predicate Device<br>and Similar to<br>Reference<br>Predicate Device |
| Method of Use | Removable and reusable<br>intraoral mandibular<br>repositioning device for a<br>single patient. | Removable and reusable<br>intraoral mandibular<br>repositioning device for<br>a single patient. | Removable and<br>reusable intraoral<br>mandibular<br>repositioning device<br>for a single patient. | Same as Primary<br>and Reference<br>Predicate Devices |
| Prescription Use<br>Only | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Target<br>Population | Adult patients 18 years<br>and older | Adult patients 18 years<br>and older | Adult patients 18<br>years and older | Same as Primary<br>and Reference<br>Predicate Devices |
| Contraindication | -Patients who have<br>central sleep apnea<br>-Patients who have<br>severe respiratory<br>disorders | -Patients who have<br>central sleep apnea<br>-Patients who have<br>severe respiratory<br>disorders | Temporomandibular<br>Joint (TMJ)<br>dysfunction | Same as Primary<br>Predicate Device<br>and Similar to<br>Reference<br>Predicate Device |
| | -Patients who have loose<br>teeth or advanced<br>periodontal disease<br>-Patients who are under<br>18 years of age<br>-Patients who have<br>Temporomandibular | -Patients who have loose<br>teeth or advanced<br>periodontal disease<br>-Patients who are under<br>18 years of age | | |
| <b>Environment of Use</b> | Joint (TMJ) dysfunction<br>To be used in the<br>patient's home and in<br>sleep laboratories | To be used in the<br>patient's home and in<br>sleep laboratories | To be used in the<br>patient's home and<br>in sleep laboratories | Same as Primary<br>and Reference<br>Predicate Devices |
| <b>Design</b> | | | | |
| Rigid tray pieces | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Separate tray<br>pieces | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Heat sensitive<br>impression<br>material for fitting<br>to teeth | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Provides full<br>occlusal coverage<br>of both arches | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Does not encroach<br>on tongue space | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Keeps the teeth<br>together and holds<br>the mandible and<br>tongue forward<br>during sleep to<br>open the airway | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Fully adjustable | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Securely<br>conforms to the<br>patient dentition | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| Patient Comfort | Yes | Yes | Yes | Same as Primary<br>and Reference<br>Predicate Devices |
| <b>Materials:</b> | | | | |
| Trays | Heat sensitive<br>impression material | Heat cure acrylic resin | Heat sensitive<br>impression<br>material | Similar to<br>Primary Predicate<br>Device and Same<br>as Reference<br>Predicate Device |

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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including blue, pink, and yellow. The company name is written in blue, with "PRISMATIK" on top and "DENTALCRAFT, INC." on the bottom.

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle with a colorful, prism-like design on the left, and the company name in blue text on the right. The text is stacked, with "PRISMATIK" on top and "DENTALCRAFT, INC." below it.

| Advancement<br>mechanism | Plastic connectors to<br>position the mandible<br>forward | Stainless Steel Herbst<br>(rod and tube)<br>mechanism to position<br>the mandible forward | Plastic connectors<br>to position the<br>mandible forward | Similar to<br>Primary Predicate<br>Device and Same<br>as Reference<br>Predicate Device |
|-----------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------|
| Fabrication<br>Technique | Thermo-molding | Thermo-molding | Thermo-molding | Same as Primary<br>and Reference<br>Predicate Devices |
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | Same as Primary<br>and Reference<br>Predicate Devices |
| Biocompatibility<br>(ISO 10993-1) | Cytotoxicity<br>Irritation<br>Sensitization | Cytotoxicity<br>Irritation<br>Sensitization | Cytotoxicity<br>Irritation<br>Sensitization | Same as Primary<br>and Reference<br>Predicate Devices |

#### G. PERFORMANCE DATA

Prismatik Dentalcraft, Inc. relies on the existing predicated devices for the safety and effectiveness of the Silent Nite® sl for its intended use. Non-clinical (bench performance testing) data was used to support the substantial equivalency.

| ASTM D570 | Water Sorption |
|-------------|----------------------------|
| ASTM D790 | Water Solubility |
| ASTM D790 | Ultimate Flexural Strength |
| ASTM D790 | Flexural Modulus |
| ISO 20795-1 | Total fracture Work |
| ASTM D638 | Yield Strength |
| ASTM D412 | Tensile Strength |
| ASTM D638 | Elongation at break |
| ISO 179 | Impact Strength |

Silent Nite® sl is provided non-sterile and the manufacturing process, material composition, design, and shelf-life is identical to Prismatik's own cleared device, SilentNite® (K972424). No new potential risks were identified and no new concerns were raised for identified risks.

Silent Nite® sl and the primary predicate device, OASYS Hinge Appliance™ (K083209), have the same indications for use and performance characteristics as well as other information on the proposed labeling that support the same intended use.

#### H. CONCLUSION

The documentation submitted in this premarket notification demonstrates that the Silent Nite® sl is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance, when used as labeled.