(236 days)
SilentNite® (K972424)
No
The description focuses on the mechanical design and materials of a mandibular advancement device and does not mention any AI or ML components or functions.
Yes
The device is intended to treat snoring and mild to moderate obstructive sleep apnea (OSA), which are medical conditions, and it works by supporting the lower jaw in a forward position to improve airflow.
No.
The device is a mandibular advancement device intended for treatment (to reduce snoring and obstructive sleep apnea) by holding the lower jaw in a forward position, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (upper tray, lower tray, connectors) made of materials like polyurethane and polyester, indicating it is a hardware device.
Based on the provided information, the Silent Nite® sl device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Silent Nite® sl Function: The Silent Nite® sl is a physical device worn by the patient to mechanically reposition the lower jaw. It directly interacts with the patient's anatomy to improve airflow during sleep. It does not analyze any biological samples.
The description clearly indicates it's a mandibular advancement device (MAD) used for the treatment of snoring and mild to moderate obstructive sleep apnea. Its function is entirely mechanical and external to the analysis of biological specimens.
N/A
Intended Use / 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.
Product codes
LRK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharynx and the oropharynx
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
prescribed by the dentist.
To be used in the patient's home and in sleep laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical (bench performance testing) data was used to support the substantial equivalency.
Tests conducted:
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
Key Metrics
Not Found
Predicate Device(s)
OASYS Hinge Appliance™ (K083209)
Reference Device(s)
SilentNite® (K972424)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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.
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 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", in blue font.
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. |
| Irvine, CA 92612 | |
| Company Phone | (949) 440-2739 |
| Company Fax | (949) 553-0924 |
| Facility Registration Number: | 2031503 |
| Primary Contact Person: | Mythili Reguraman |
| 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 |
| devices for snoring and obstructive sleep | |
| 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
Silent Nite® sl | Primary Predicate
Device
OASYS Hinge
ApplianceTM | Reference
Predicate
Device
SilentNite® | Comparison |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Trade Name | | | | |
| 510(k) | K183270 | K083209 | K972424 | |
| Regulatory
Classification | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | Same as Primary
and Reference
Predicate Devices |
| Product Code | LRK | LRK | LRK | Same as Primary
and Reference
Predicate Devices |
| Classification | II | II | Unclassified | Same as Primary
Predicate Device |
| Intended Use | Snore Prevention and
Treatment of Obstructive
Sleep Apnea | Snore Prevention and
Treatment of Obstructive
Sleep Apnea | Snore Prevention
and Treatment of
Obstructive Sleep
Apnea | Same as Primary
and Reference
Predicate Devices |
| Indications for
Use | 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. | To reduce snoring and
mild to moderate
obstructive sleep apnea
(OSA) in patients 18
years of age or older.
The appliance is worn
while sleeping to support
the lower jaw in a
forward position
prescribed by the dentist.
The appliance is
removable by the patient. | Refer to Indications
for Use statement of
K972424. | Same as Primary
Predicate Device
and Similar to
Reference
Predicate Device |
| Method of Use | Removable and reusable
intraoral mandibular
repositioning device for a
single patient. | Removable and reusable
intraoral mandibular
repositioning device for
a single patient. | Removable and
reusable intraoral
mandibular
repositioning device
for a single patient. | Same as Primary
and Reference
Predicate Devices |
| Prescription Use
Only | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Target
Population | Adult patients 18 years
and older | Adult patients 18 years
and older | Adult patients 18
years and older | Same as Primary
and Reference
Predicate Devices |
| Contraindication | -Patients who have
central sleep apnea
-Patients who have
severe respiratory
disorders | -Patients who have
central sleep apnea
-Patients who have
severe respiratory
disorders | Temporomandibular
Joint (TMJ)
dysfunction | Same as Primary
Predicate Device
and Similar to
Reference
Predicate Device |
| | -Patients who have loose
teeth or advanced
periodontal disease
-Patients who are under
18 years of age
-Patients who have
Temporomandibular | -Patients who have loose
teeth or advanced
periodontal disease
-Patients who are under
18 years of age | | |
| Environment of Use | Joint (TMJ) dysfunction
To be used in the
patient's home and in
sleep laboratories | To be used in the
patient's home and in
sleep laboratories | To be used in the
patient's home and
in sleep laboratories | Same as Primary
and Reference
Predicate Devices |
| Design | | | | |
| Rigid tray pieces | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Separate tray
pieces | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Heat sensitive
impression
material for fitting
to teeth | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Provides full
occlusal coverage
of both arches | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Does not encroach
on tongue space | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Keeps the teeth
together and holds
the mandible and
tongue forward
during sleep to
open the airway | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Fully adjustable | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Securely
conforms to the
patient dentition | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Patient Comfort | Yes | Yes | Yes | Same as Primary
and Reference
Predicate Devices |
| Materials: | | | | |
| Trays | Heat sensitive
impression material | Heat cure acrylic resin | Heat sensitive
impression
material | Similar to
Primary Predicate
Device and Same
as Reference
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
mechanism | Plastic connectors to
position the mandible
forward | Stainless Steel Herbst
(rod and tube)
mechanism to position
the mandible forward | Plastic connectors
to position the
mandible forward | Similar to
Primary Predicate
Device and Same
as Reference
Predicate Device |
|-----------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------------------------|
| Fabrication
Technique | Thermo-molding | Thermo-molding | Thermo-molding | Same as Primary
and Reference
Predicate Devices |
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | Same as Primary
and Reference
Predicate Devices |
| Biocompatibility
(ISO 10993-1) | Cytotoxicity
Irritation
Sensitization | Cytotoxicity
Irritation
Sensitization | Cytotoxicity
Irritation
Sensitization | Same as Primary
and Reference
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.