K Number

Device Name

The NightBlocks Appliance

Manufacturer

Advanced Facialdontics LLC

Date Cleared

2020-01-28

(131 days)

Product Code

LQZ LOZ LRK

Regulation Number

872.5570

Intended Use

The NightBlocks™ Appliance is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The NightBlocks™ Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

Device Description

The NightBlocks™ appliance consist of two removable, custom fabricated acrylic trays that fit separately over the upper and lower dental arches and engage each other in order to reposition the mandible in a slightly anterior position. They contain stainlesssteel ball clasps for extra retention and stainless-steel orthodontic expansion screws on the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting. The principal of operation is jaw repositioning. Worn during sleep, the NightBlocks™ function as a mandibular advancement device which acts to increase the patient's pharyngeal airway space, improving their ability to exchange air during sleep. The anterior repositioning of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be larger, contributing to the reduction in snoring and mild to moderate sleep apnea. Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K130130

Reference Devices

K162816, K101709

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components and jaw repositioning, with no mention of AI, ML, or data processing for diagnosis or treatment adjustment.

Therapeutic

Yes
The device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea, which are conditions indicative of therapeutic intervention.

Diagnostic

Explanation: The device is intended to treat snoring and sleep apnea by repositioning the jaw, which is a therapeutic function, not a diagnostic one. It does not identify or analyze a medical condition.

SaMD (Software as a Medical Device)

The device description clearly details physical components made of acrylic and stainless steel, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the NightBlocks™ Appliance is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
NightBlocks™ Function: The NightBlocks™ Appliance is a physical device worn in the mouth to reposition the jaw and improve airflow during sleep. It does not analyze any biological specimens.
Intended Use: The intended use is to reduce snoring and sleep apnea by physically altering the airway, not by analyzing biological samples.

Therefore, the NightBlocks™ Appliance falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LOZ, LRK

Device Description

The principal of operation is jaw repositioning. Worn during sleep, the NightBlocks™ function as a mandibular advancement device which acts to increase the patient's pharyngeal airway space, improving their ability to exchange air during sleep. The anterior repositioning of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be larger, contributing to the reduction in snoring and mild to moderate sleep apnea.

Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral cavity / pharyngeal airway

Indicated Patient Age Range

adults

Intended User / Care Setting

Prescribed and adjusted by the dentist; worn by the patient in the home setting.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests:
A risk analysis was performed as per ISO 14971 which considered intraoral soreness, obstruction of oral breathing, tooth movement or loosening, TMD concerns, excessive saliva and breakage. The subject device was compared to the predicate in each area to show the risks were equivalent or less to the predicate device.

Clinical Tests:
Clinical testing has not been performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

ATG/SM-OSA Appliances (K130130)

Reference Device(s)

SML-OSA2 Appliances (K162816), Lamberg Sleep Well-Smartrusion, LSW-S (K101709)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

Summary

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 acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.

January 28, 2020

Advanced Facialdontics LLC Scott Simonetti President 325 Lake Ave. Unit 759 St James, New York 11780

Re: K192581

Trade/Device Name: The NightBlocks Appliance 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: LOZ, LRK Dated: December 17, 2019 Received: December 19, 2019

Dear Scott Simonetti:

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.

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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K192581

Device Name The NightBlocks™ Appliance

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)

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nced Facialdontics®

510(k) Summary

1. Owner Information

Owner's Name:	Advanced Facialdontics LLC
Owner's Address:	325 Lake Ave
Unit 759
St James, NY 11780
FDA Registration #:	3015733038
Telephone:	(631) 379-3902
Fax:	(631) 234-7985
Contact Person:	Dr Scott Simonetti
Email:	ssimonettidds@yahoo.com
Date Prepared:	1/10/2020

2. Device Name

Trade Name:	The NightBlocks™ Appliance
510K Number:	K192581
Common Name:	Device, Jaw Repositioning
Classification:	Class II
Product Code:	LQZ, LRK
Review Panel:	Dental
Regulation:	CFR 872.5570

3. Predicate Devices

Primary Predicate:	ATG/SM-OSA Appliances (K130130)
Reference Devices:	SML-OSA2 Appliances (K162816)
Lamberg Sleep Well-Smartrusion, LSW-S (K101709)

4. Device Description

the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting.

Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).

5. Indications for Use:

6. Technological Characteristics Comparison to Predicate Device:

Intended Use: The intended use and the Indications of Use for the proposed device and predicate are identical.

Technological Characteristics: The predicate and the subject device have the exact same following technological characteristics:

Principle of operation, Indications of Use, Prescription device custom fabricated, intraoral jaw repositioning device for sleep apnea, environment of use: home, removable by patient and reusable, location of advancement mechanism, provided nonsterile, and identical raw materials, manufacturing, finishing and cleaning process.

The only minor design differences between the proposed device and predicate is the location of the occluding surface of the upper and lower trays, and the inclusion of additional braided stainless-steel supporting wire within the dorsal wings.

	Subject Device	Predicate Device	Reference Device	Reference Device
Device	NightBlocks™
Appliance	ATG/SM-OSA,
Adjustable Dorsal
Appliance
K130130	SML-OSA2
Appliances
K162816	Lamberg Sleep
Well Smartrusion
K101709
Product Codes	LQZ, LRK	LQZ, LRK	LQZ, LRK	LQZ, LRK
Indications
for Use	The NightBlocks™
Appliance is intended
to reduce nighttime
snoring and mild to
moderate obstructive
sleep apnea in adults.
The NightBlocks™
Appliance is worn
while sleeping to
support the lower jaw
in a forward position
prescribed by the
dentist. The
customized appliance
is inserted and
removed by the
patient and adjusted
by the prescribing
dentist.	The ATG/SM-OSA
Appliances are
intended to reduce
nighttime snoring and
mild to moderate
obstructive sleep
apnea in adults. The
ATG/SM-OSA
appliances are worn
while sleeping to
support the lower jaw
in a forward position
prescribed by the
dentist. The
customized appliance
is inserted and
removed by the
patient and adjusted
by the prescribing
dentist.	The SML-OSA2
Appliances are
intended to reduce
nighttime snoring
and mild to
moderate
obstructive sleep
apnea in adults. The
SML-OSA2
appliances are worn
while sleeping to
support the lower
jaw in a forward
position prescribed
by the dentist. The
customized
appliance is
inserted and
removed by the
patient and
adjusted by the
prescribing dentist.	For the reduction
of nighttime
snoring and mild
to moderate
obstructive sleep
apnea in adults 18
years of age or
older. Prescription
use only.
Target
Population	Adults who snore or
have obstructive
sleep apnea.	Same	Same	Same
Design
Features	Prescription device
custom fit	Same	Same	Same
	Intraoral device fitted
over upper and lower
dentition	Same	Same	Same
Sterility	Provided Non-sterile	Same	Same	Same
Human
Factors	Removable by patient
and reusable	Same	Same	Same
Environment
of Use	Home	Same	Same	Same
Principle of
Operation	Mandibular
Repositioning with
custom fitted acrylic
upper and lower
components. This
advances the
mandible anteriorly
to enlarge the airway.	Same	Same	Same
	Expansion mechanism
placed on buccal
portions for
unobstructed airway
passage.	Same	Same	Expansion
mechanism
located in anterior
portion of mouth.
	Mandible can be
advanced with two
buccal expansion
screws up to 6mm.	Same	Varying
advancement
mechanisms.	Advancement by
dentist adding
acrylic material to
the anterior
protrusive element
Materials	Methyl methacrylate,
medical grade
stainless steel,
Orthodontic
Expansion screws	Same, and additional
colorant	Same	Methyl
methacrylate,
Stainless steel, and
copolyester.
Biocompatibility	Uses all FDA cleared
Class I materials that
are commonly used in
dentistry.	Same	Same	Same
Compatibility
with the
environment
and other
devices	Does not release any
compounds harmful
to the environment
and pother devices.	Same	Same	Same
Electrical,
radiation,
chemical, and
thermal
safety	The device does not
use electricity,
radiation, heat or
chemicals to function.	Same	Same	Same

Table 1: Comparison of Intraoral Jaw Repositioning Devices

7. Non-Clinical Tests Performed

The materials used in the predicate device are identical to those in the subject device, but without the colorant. The three raw materials are obtained from the same manufacturers (Lang Dental Orthodontic Acrylic K141439, medical grade stainless steel orthodontic wire from AJ Wilcock, and stainless-steel orthodontic expansion screws from Leone). Both the predicate device and the subject device are manufactured in the same manufacturing facility (Space Maintainers Laboratory). The manufacturing process and sterilization and cleaning process of the predicate device and the subject device are identical. Biocompatibility and physical properties have been leveraged from the predicate.

A risk analysis was performed as per ISO 14971 which considered intraoral soreness, obstruction of oral breathing, tooth movement or loosening, TMD concerns, excessive saliva and breakage. The subject device was compared to the predicate in each area to show the risks were equivalent or less to the predicate device.

8. Clinical Tests Performed

Clinical testing has not been performed.

9. Conclusion

The subject device has the identical Indications of Use, intended use, materials of construction, sterilization and processing, principle of operation and technological characteristics as the predicate device. The devices are both manufactured, finished and shipped from the same FDA registered facility. Based upon the comparative analysis of features, materials and design, the minor design difference between the subject device and the predicate device does not affect the substantial equivalence of the subject device since: it does not change the Indication of Use of the subject device, it does not change the principle of operation, it does not change the manufacturing or sterilization process, and it does not elevate the risk. It is concluded that the proposed NightBlocks™ Appliance is substantially equivalent to the previously cleared device.