Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. It 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

The Silent Nite Sleep Appliance with the Glidewell Hinge is a mandibular advancement device. It holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep. The device consists of upper and lower trays, which are fabricated using a biocompatible dual-layered thermoplastic material, and an engaging mechanism, which is the Glidewell Hinge (biocompatible medical grade stainless steel bars), and band lugs and hooks for attaching the optional orthodontic (elastic) bands, which are provided as accessories. The trays consist of a soft polyurethane inner layer that provides patient comfort and a hard polyester outer layer for durability. The hinge is adjustable by turning an inner adjustment screw with a hex driver, enabling the amount of mandibular advancement prescribed by the clinician. The design allows for the advancement of the mandible to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. The orthodontic bands accessories are used to aid in holding the mouth closed. The end result, a forward position of the jaw, is the same as the predicate, however, the method of action of the predicate device and subject device are slightly different. Silent Nite Sleep Appliance with the Glidewell Hinge's method of action is identical to the Reference device and both use orthobands. Without orthobands, the patient's mouth can open during sleep which allows the tongue to fall back into the airway. The orthobands help keep the mouth closed to avoid this. With just a slight protrusion, the orthobands can be placed on the provided hooks. More protrusion requires the orthoband to be placed on the forward hook and the band lug. The device is customized to conform to the patient's upper and lower dentition based on the clinician's prescription. Upon receipt of the prescription, models for the trays are made and used during the thermoforming fabrication of the upper and lower trays. The difference between the Silent Nite Sleep Appliance with the Glidewell Hinge and the Primary Predicate Silent Nite sl is the mechanism connecting the trays: The new device's stainless steel hinge allows adjustment within the mechanism, while the Predicate's adjustment requires changing the plastic connectors. This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "Silent Nite Sleep Appliance with the Glidewell Hinge." It describes the device, its intended use, and how it compares to a predicate device to establish substantial equivalence for FDA clearance.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them, primarily focusing on the engineering and material performance rather than clinical efficacy studies, as this is a 510(k) submission for a physical device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria detailed in the document are primarily related to the device's functional integrity, fit, and material biocompatibility. Clinical efficacy (e.g., reduction in AHI) is established through the similarity to the predicate device, not through new clinical trials described here.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Assessment Method
Functional Attributes	Mandibular advancement function correct	- Verification testing conducted by Prismatik Dentalcraft, Inc.- Device design allows for advancement to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. This indicates the function works as intended.
	Maximum hinge displacement (mm) correct	- Verification testing conducted by Prismatik Dentalcraft, Inc.- Specific maximum displacement (up to 10mm) is stated, implying it meets this range.
	Hinge placement/positioning correct	- Verification testing conducted by Prismatik Dentalcraft, Inc.
	Device fits and retains to the model	- Validation testing showed acceptable performance.- Customized to conform to the patient's upper and lower dentition based on clinician's prescription; models are made and used during thermoforming fabrication.
	Hinge is well attached to the trays	- Validation testing showed acceptable performance.
	Device's final finish is smooth and free of roughness or burs	- Validation testing showed acceptable performance.
Biocompatibility	Materials meet ISO 10993 requirements (trays)	- ISO 10993 testing performed on Thermoforming Sheet Materials (documented in Reference device K200125).- Material is safe and biocompatible for "fabrication of orthodontic and dental appliances." - Tests include Cytotoxicity and Irritation (implied, as it matches predicate's requirements).
	Materials meet ISO 10993 requirements (stainless steel hinge)	- ISO 10993 testing conducted on the stainless steel hinge component: - In vitro Cytotoxicity (Part 5): Met requirements. - Guinea Pig Maximization Sensitization (Part 10): Met requirements. - Oral Mucosal Irritation in Hamsters: 14 days (Part 10): Met requirements.- Test article deemed safe and biocompatible for the intended use.
Manufacturing Process	Verification and validation of manufacturing process	- Verification and validation performed by Prismatik Dentalcraft, Inc.- Led to acceptable performance for functional attributes and physical finish.
"Clinical" Equivalence	Intended uses are the same as predicate	- "To reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older." - Confirmed as same.
	Mechanisms of action are the same	- "Holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep." - Confirmed as same. The minor difference in how the action is achieved (adjustability mechanism) was addressed by V&V testing.
	Materials for trays are the same as predicate	- "Heat-sensitive impression dual-layer material." - Confirmed as same.
	Manufacturing methods similar	- Confirmed as similar.
	Non-sterile	- Device is non-sterile. - Confirmed as same as predicate.
	Prescription Use Only; Single patient use, removable, reusable	- Confirmed as same.
	Environment of Use: In patient's home or sleep laboratory	- Confirmed as same.

Study Details Proving Device Meets Acceptance Criteria

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify discrete sample sizes for the functional and manufacturing verification/validation tests. These types of tests typically involve testing a representative number of units from manufacturing runs.
The data provenance is from Prismatik Dentalcraft, Inc. (the manufacturer), indicating these are internal company tests, likely conducted as part of their quality management system for product development and release. The tests are prospective in the sense that they are performed on newly manufactured devices to confirm design specifications and manufacturing quality.
No specific country of origin for the data is mentioned, but the manufacturer is based in Irvine, CA (USA), implying the testing was conducted under US regulatory considerations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document details engineering and biocompatibility testing, not clinical studies requiring expert ground truth in the diagnostic sense. Therefore, experts in this context would be test engineers, quality control personnel, and lab technicians. Their qualifications are not specified but would be implicit in their roles within the manufacturing and testing environment (e.g., trained in verification/validation, ISO standards, good laboratory practices).

4. Adjudication Method for the Test Set:
Not applicable in the sense of clinical image review or diagnostic agreement. Adjudication would be based on objective criteria defined in the test protocols (e.g., measurement within tolerance, pass/fail result for biocompatibility tests). Deviations would be addressed through standard quality control and engineering procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No MRMC comparative effectiveness study was described or required. This is a 510(k) submission for a physical medical device, not an AI/software device that would typically involve human reader performance studies. The substantial equivalence relies on the device's design, materials, and mechanism of action being sufficiently similar to a legally marketed predicate, backed by engineering and biocompatibility testing. The predicate device's clinical effectiveness is already established.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This isn't an algorithm or AI device. The testing described is for the physical device itself.

7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by engineering specifications, material standards (ISO 10993), and functional design requirements. For example, the ground truth for "mandibular advancement function correct" is that the device can reliably achieve the specified 0.25 mm increments up to 10 mm. For biocompatibility, the ground truth is "met requirements of each test" according to ISO 10993.

8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning product that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set is relevant for this type of device.

In summary, this 510(k) submission establishes substantial equivalence for a physical medical device based on engineering verification and validation, biocompatibility testing, and comparison of design and intended use to a predicate device, rather than clinical efficacy trials or AI/software performance studies.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

June 16, 2021

Prismatik Dentalcraft, Inc. % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K210694

Trade/Device Name: Silent Nite Sleep Appliance with the Glidewell Hinge 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 13, 2021 Received: May 17, 2021

Dear Patsy Trisler:

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.

{1}------------------------------------------------

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 mediation-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.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210694

Device Name

Silent Nite Sleep Appliance with the Glidewell Hinge

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary – K210694

Submitter Name:	Prismatik Dentalcraft, Inc.
Submitter Address:	2144 Michelson DriveIrvine, CA 96212
Contact Person:	Herbert SchoenhoeferDirector of RA/QA
Telephone:	949.440.2632
Date Prepared:	May 13, 2021
Device Trade Name:	Silent Nite Sleep Appliance with the Glidewell Hinge
Common Name	Anti-Snoring Device
Classification Nameand NumberProduct CodeRegulatory Class	Intraoral devices for snoring and for obstructive sleep apnea21 CFR 872.5570LRKII
Primary PredicateDevice:	K183270, Silent Nite sl, Prismatik Dentalcraft, Inc. (LRK)
Reference Devicesand Product Codes:	Reference #1: K200125, Thermoforming Sheet Materials,Erkodent Erich Kopp GmbH (MQC, KMY)Reference #2: K083209, Acrylic Herbst Splint Appliance,Specialty Appliances Works (LRK)
Indications for UseStatement:	Silent Nite Sleep Appliance with the Glidewell Hinge is indicatedto reduce snoring and mild to moderate obstructive sleep apnea(OSA) in patients 18 years of age or older. It is worn whilesleeping to support the lower jaw in a forward position prescribedby the dentist. The appliance is removable by the patient.
Device Description.Mechanism of Action,and Summary ofTechnologicalCharacteristics	The Silent Nite Sleep Appliance with the Glidewell Hinge is amandibular advancement device. It holds the mandible in aprotrusive position to increase the patient's ability to exchange airand decrease air turbulence, thus improving airflow during sleep.The device consists of upper and lower trays, which are fabricatedusing a biocompatible dual-layered thermoplastic material, and anengaging mechanism, which is the Glidewell Hinge (biocompatiblemedical grade stainless steel bars), and band lugs and hooks forattaching the optional orthodontic (elastic) bands, which areprovided as accessories.The trays consist of a soft polyurethane inner layer that providespatient comfort and a hard polyester outer layer for durability. Thehinge is adjustable by turning an inner adjustment screw with ahex driver, enabling the amount of mandibular advancement

{4}------------------------------------------------

prescribed by the clinician. The design allows for the advancement of the mandible to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm.

The orthodontic bands accessories are used to aid in holding the mouth closed. The end result, a forward position of the iaw, is the same as the predicate, however, the method of action of the predicate device and subject device are slightly different. Silent Nite Sleep Appliance with the Glidewell Hinge's method of action is identical to the Reference device and both use orthobands. Without orthobands, the patient's mouth can open during sleep which allows the tongue to fall back into the airway. The orthobands help keep the mouth closed to avoid this. With just a slight protrusion, the orthobands can be placed on the provided hooks. More protrusion requires the orthoband to be placed on the forward hook and the band lug.

The device is customized to conform to the patient's upper and lower dentition based on the clinician's prescription. Upon receipt of the prescription, models for the trays are made and used during the thermoforming fabrication of the upper and lower trays.

The difference between the Silent Nite Sleep Appliance with the Glidewell Hinge and the Primary Predicate Silent Nite sl is the mechanism connecting the trays: The new device's stainless steel hinge allows adjustment within the mechanism, while the Predicate's adjustment requires changing the plastic connectors.

This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.

Device Testing Laboratory Testing

Verification and validation of the manufacturing process was performed by Prismatik Dentalcraft, Inc.

Verification testing was conducted to assure the following functional attributes of the finished device were correct:

Mandibular advancement function ●
Maximum hinge displacement (mm) ●
Hinge placement/positioning .

Validation showed that the following were acceptable:

Device fits and retains to the model
Hinge is attached well to the trays ●
Device's final finish is smooth and free of roughness or burs

Biocompatibility

ISO 10993 testing was performed to assess the safety and biocompatibility of the Thermoforming Sheet Materials and documentation was provided in the 510(k) for the Reference device. K200125. The testing showed the material is safe and biocompatible for the intended use "fabrication of orthodontic and dental appliances".

{5}------------------------------------------------

The following biocompatibility testing was conducted according to Good Laboratory Practices and per ISO 10993 on the stainless steel hinge component of the device:

In vitro Cytotoxicity (Part 5)
. Guinea Pig Maximization Sensitization (Part 10)
. Oral Mucosal Irritation in Hamsters:14 days (Part 10)

The test article met the requirements of each test and is safe and biocompatible for the intended use.

Animal | Human Testing

No animal or human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by method similar to the predicate device.

Comparison to Predicate Device:

Refer to the Comparison Table below for similarities and differences between Silent Nite Sleep Appliance with the Glidewell Hinge and the Primary Predicate device. In summary:

The intended uses are the same.
. The mechanisms of actions are the same.
. The materials used for the trays are the same as the Predicate and Reference #1.
I The methods used for manufacturing the appliances are similar.
. The materials used for the connector mechanism are different and the design for adjusting the jaw position is different, as follows:

The technological design of the subject device allows for microadjustments of the mandibular position to achieve the needed improvement in airflow during sleep, which is similar to Reference #2, while the Predicate device allows for millimeter incremental adjustment. Reference #2 also includes the optional orthobands like the subject device, but unlike the Predicate.

The design and material differences in the connector mechanism do not raise different questions of safety and effectiveness, and were addressed with standard verification and validation testing submitted in the 510(k).

Based on the documentation presented in the 510(k), as Substantial summarized above and the following side-by-side comparison, it Equivalence can be concluded subject device is substantially equivalent to the Conclusion predicate device.

{6}------------------------------------------------

Substantial Equivalence Comparison Table
Element	New Device	Primary Predicate	Comparison
Device name:	Silent Nite Sleep Appliancewith the Glidewell Hinge	Silent Nite® sl	N/A
510(k) #:	K210694	K183270
RegulatoryClassification:Product Code:Class:	21 CFR 872.5570LRKII	21 CFR 872.5570LRKII	Same
Submitter:	Prismatik Dentalcraft, Inc.	Prismatik Dentalcraft, Inc.	Same
Indications for Use:	To reduce snoring and mildto moderate obstructivesleep apnea (OSA) inpatients 18 years of age orolder. Silent Nite with theGlidewell Hinge is worn whilesleeping to support the lowerjaw in a forward positionprescribed by the dentist.The appliance is removableby the patient.	To reduce snoring and mildto moderate obstructivesleep apnea (OSA) inpatients 18 years of age orolder. Silent Nite® sl isworn while sleeping tosupport the lower jaw in aforward position prescribedby the dentist. Theappliance is removable bythe patient.	Same
Method of Use:	Single patient use,removable and reusableappliance	Single patient use,removable and reusableappliance	Same
Prescription UseOnly:	Yes	Yes	Same
Environment ofUse:	In patient's home or in sleeplaboratory	In patient's home or insleep laboratory	Same
DESIGN:
Rigid Trays	Yes	Yes	Same
Adjustable	Yes	Yes	Same
MATERIALS:
Trays:	Heat-sensitive impressiondual-layer material	Heat-sensitive impressiondual-layer material	Same asPrimaryPredicate andReference #1
AdvancementMechanism:	Stainless steel rod and tubemechanism to position themandible forward	Plastic connectors toposition the mandibleforward	Similar toPrimaryPredicate andsame asReference #2
STERILITY:	Non-sterile	Non-sterile	Same
BIOCOMPATIBILITY	All materials meetrequirements of ISO 10993:• Cytotoxicity• Irritation	All materials meetrequirements of ISO 10993:• Cytotoxicity• Irritation	Same

Substantial Equivalence Comparison Table

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.”