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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Silent Nite® sl device. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, this document does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria through clinical data or AI model performance metrics.

The "Performance Data" section explicitly states: "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."

The listed tests (ASTM D570, ASTM D790, ISO 20795-1, ASTM D638, ASTM D412, ISO 179) are all bench (material and mechanical) tests, not clinical studies involving human subjects or AI model performance evaluation.

Therefore, I cannot fulfill the request for information regarding:

A table of acceptance criteria and reported device performance (for clinical/AI performance)
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method for the test set
MRMC comparative effectiveness study results or effect size
Standalone (algorithm-only) performance
Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Sample size for the training set
How ground truth for the training set was established

This 510(k) relies on the substantial equivalence principle based on design, materials, manufacturing process, and bench testing, rather than a new clinical study to establish efficacy or an AI model's performance.

Summary

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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 (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 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
Indications for Use
	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)	Prescription Use (Part 21 CFR 801 Subpart D) 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.

Company Name:	Prismatik Dentalcraft, Inc.
Company Address:	2181 Dupont Dr.Irvine, CA 92612
Company Phone	(949) 440-2739
Company Fax	(949) 553-0924
Facility Registration Number:	2031503
Primary Contact Person:	Mythili ReguramanRA/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 intraoraldevices for snoring and obstructive sleepapnea
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.

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

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 DeviceSilent Nite® sl	Primary PredicateDeviceOASYS HingeApplianceTM	ReferencePredicateDeviceSilentNite®	Comparison
Trade Name
510(k)	K183270	K083209	K972424
RegulatoryClassification	21 CFR 872.5570	21 CFR 872.5570	21 CFR 872.5570	Same as Primaryand ReferencePredicate Devices
Product Code	LRK	LRK	LRK	Same as Primaryand ReferencePredicate Devices
Classification	II	II	Unclassified	Same as PrimaryPredicate Device
Intended Use	Snore Prevention andTreatment of ObstructiveSleep Apnea	Snore Prevention andTreatment of ObstructiveSleep Apnea	Snore Preventionand Treatment ofObstructive SleepApnea	Same as Primaryand ReferencePredicate Devices
Indications forUse	To reduce snoring andmild to moderateobstructive sleep apnea(OSA) in patients 18years of age or older.Silent Nite sl is wornwhile sleeping to supportthe lower jaw in aforward positionprescribed by the dentist.The appliance isremovable by the patient.	To reduce snoring andmild to moderateobstructive sleep apnea(OSA) in patients 18years of age or older.The appliance is wornwhile sleeping to supportthe lower jaw in aforward positionprescribed by the dentist.The appliance isremovable by the patient.	Refer to Indicationsfor Use statement ofK972424.	Same as PrimaryPredicate Deviceand Similar toReferencePredicate Device
Method of Use	Removable and reusableintraoral mandibularrepositioning device for asingle patient.	Removable and reusableintraoral mandibularrepositioning device fora single patient.	Removable andreusable intraoralmandibularrepositioning devicefor a single patient.	Same as Primaryand ReferencePredicate Devices
Prescription UseOnly	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
TargetPopulation	Adult patients 18 yearsand older	Adult patients 18 yearsand older	Adult patients 18years and older	Same as Primaryand ReferencePredicate Devices
Contraindication	-Patients who havecentral sleep apnea-Patients who havesevere respiratorydisorders	-Patients who havecentral sleep apnea-Patients who havesevere respiratorydisorders	TemporomandibularJoint (TMJ)dysfunction	Same as PrimaryPredicate Deviceand Similar toReferencePredicate Device
	-Patients who have looseteeth or advancedperiodontal disease-Patients who are under18 years of age-Patients who haveTemporomandibular	-Patients who have looseteeth or advancedperiodontal disease-Patients who are under18 years of age
Environment of Use	Joint (TMJ) dysfunctionTo be used in thepatient's home and insleep laboratories	To be used in thepatient's home and insleep laboratories	To be used in thepatient's home andin sleep laboratories	Same as Primaryand ReferencePredicate Devices
Design
Rigid tray pieces	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Separate traypieces	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Heat sensitiveimpressionmaterial for fittingto teeth	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Provides fullocclusal coverageof both arches	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Does not encroachon tongue space	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Keeps the teethtogether and holdsthe mandible andtongue forwardduring sleep toopen the airway	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Fully adjustable	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Securelyconforms to thepatient dentition	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Patient Comfort	Yes	Yes	Yes	Same as Primaryand ReferencePredicate Devices
Materials:
Trays	Heat sensitiveimpression material	Heat cure acrylic resin	Heat sensitiveimpressionmaterial	Similar toPrimary PredicateDevice and Sameas ReferencePredicate 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.

Advancementmechanism	Plastic connectors toposition the mandibleforward	Stainless Steel Herbst(rod and tube)mechanism to positionthe mandible forward	Plastic connectorsto position themandible forward	Similar toPrimary PredicateDevice and Sameas ReferencePredicate Device
FabricationTechnique	Thermo-molding	Thermo-molding	Thermo-molding	Same as Primaryand ReferencePredicate Devices
Sterility	Provided non-sterile	Provided non-sterile	Provided non-sterile	Same as Primaryand ReferencePredicate Devices
Biocompatibility(ISO 10993-1)	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization	CytotoxicityIrritationSensitization	Same as Primaryand ReferencePredicate 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.

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”