(76 days)
Not Found
No
The device description details a mechanical mandibular advancement device with manual adjustment. There is no mention of software, algorithms, or any technology that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for medical conditions such as benign snoring, obstructive sleep apnea, and sleep bruxism, which are health-related issues that a therapeutic device aims to treat or alleviate.
No
Explanation: The provided text describes SleepBite as a mandibular advancement device used for treating snoring and sleep bruxism. It is a therapeutic device that changes the mechanical position of the jaw, not a device that diagnoses a condition.
No
The device description clearly describes a physical, double plate mandibular advancement device with a calibrated advancement screw and elastomeric tubes. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- SleepBite's Function: SleepBite is a physical device that is placed in the mouth to mechanically adjust the position of the mandible. It directly interacts with the patient's anatomy to treat conditions like snoring and sleep apnea. It does not analyze biological specimens to provide diagnostic information.
The provided information clearly describes a physical medical device used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
SleepBite is prescribed for the patient by the healthcare professional.
- A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
- B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Bite is indicated for ass in for obstructive sleep apnea.
- C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. The screw is located on the anterior segment of the lower plate and extends slightly between the lips. A small adjustment wrench is used to turn the screw, and thereby, it allows the mandible to be anteriorized relative to the maxilla. The clinician can determine the magnitude of the advancement via a calibrated scale which part of the screw itself. The scale is marked in 2mm units. The connectors between the upper and lower plates are flexible elastomeric tubes that have the ability to remain sufficiently rigid to hold the mandible sufficiently open while they also allow complete lateral movement of the mandible in use and of thin ethylene vinyl sufficiently to permit oral breathing. The dental places our of market the way space. The difference in SleepBite is that it has an anterior adjustment screw that (a) enables the magnitude clinician to serial advance the mandiolo in this. In this can be done by turning the screw while the patient is wearing the appliance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
of Specialized Dental Technology
WILLIAM A. BELFER, D.M.D., M.Sc.D.
JAN 3 0 2002
804 West Park Avenue, Ocean Township
New Jersey 07712
732-493-4747 - Fax 732-493-4742
510(k) Summary
Nov. 10, 2001
William A. Belfer, DMD Dental Imagineers 804 West Park Avenue Ocean, New Jersey 07712
Phone: (732) 493-4747 Fax: (732) 493-4742
SleepBite (proposed) Device/Trade Name: Mandibular Advancement Device (MAD) Descriptive Name: Anti-snoring Device Common Name:
Device, Anti-snoring Classification Name:
Substantial Equivalence Devices: The SleepBite appliance is substantially equivalent Substailersic Mandibular Appliance, also referred to as EMA, K971724. It is also substantially equivalent to the Silent Nite appliance, K972424.
Description: SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. The screw is located on the anterior segment of the lower plate and extends slightly between the lips. A small adjustment wrench is used to turn the screw, and thereby, it allows the mandible to be anteriorized relative to the maxilla. The clinician can determine the magnitude of the advancement via a calibrated scale which part of the screw itself. The scale is marked in 2mm units.
1
The connectors between the upper and lower plates are flexible elastomeric tubes that The connectors between the upper alls iown particles advancement of the mandible
have the ability to remain sufficiently rigid to college the mandible to open have the ability to remain surficiently right of personalisms the mandible to open while they also allow complet lateral monomia in use and of thin ethylene vinyl
sufficiently to permit oral breathing. The dentil not riminge on freeway space. sufficiently to permit oral breathing. The demal places our of market the way space.
Intended Use: Sleep Bite is prescribed for the patient by the healthcare professional.
- A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
- B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Dite is indreated its testing for obstructive sleep apnea.
- C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.
Technological Characteristics: SleepBite, Silent Nite and EMA are all dual plate Technological Characteristics: Steeping, one readed by flexible comectors that appliances in which the upper and lower plates are concess the adjustment of
hold the mandible in an advanced position. With the predicate devices the adjustment of hold the mandible in an advanced position. With are propriate league connector in order to hold the the appliance is made be selecting the appential single . The appliances are supplied mandible in the most effective posture to open the clinician must tremove these appliances
with a kit of connectors of various sizes. The climician must remove a special plan with a kit of connectors of various sizes. The children Nite requires a special plier to attach the connector to the structure.
The difference in SleepBite is that it has an anterior adjustment screw that (a) enables the mannitude The difference in SleepBite is that it has an and for enams. (0) visualize the magnitude clinician to serial advance the mandiolo in this. In this can be done by turning the screw while the patient is wearing the appliance.
There are differences in the vertical/diagonal direction of the comectors. Both EMA and There are differences in the vertical unagotial of the lower plate to the anterior.
Silent Nite have connector which go from the posterior of the plates. The Silent Nite have connector which go iron the buccal aspect of the plates. The of the upper plate and attached to shilli batterior plate in the first molar ates on the SleepBite connector attaches to the upper posses from and attaches to the rigid wire buccal side of the acryne plate, willie the other varies enable the devices to advance the mandible by reciprocal action.
Conclusion: SleepBite is appropriate for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Mr. William A. Belfer President Dental Imagineers & Associates 804 West Park Avenue Ocean, New Jersey 07712
Re: K013808
Trade/Device Name: SleepBite Regulation Number: None Regulation Name: Device, Anti-Snoring Regulatory Class: Unclassified Product Code: LRK Dated: November 11, 2001 Received: November 15, 2001
Dear Mr. Belfer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller bro(s) procession 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 interstate comments, or to truy 20, 1978, entreasified in accordance with the rrovisions of Amendments, of to devices mat nave obon recuire approval of a prematice approval of a premarket the Federal Pood, Drug, and Cosmetto , therefore, market the device, subject to the general approval application (1 Mr.). - Four general controls provisions of the Act include controls provisions of the Fist - 100 - 11sting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (See aboutional controls. Existing major regulations affecting (PMA), it may be subject to Such addines from Regulations, Title 21, Parts 800 to 898. In the Coderel your device can be found in the Sous recements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DTS issuaires on that your device complies with other requirements meall that IDA has made a deceminations administered by other Federal agencies.
3
Page 2 - Mr. Belfer
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou mast comply with and are reveling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), idocling (21 cegulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter will anow you to begin marketing your substantial equivalence of your device to 310(K) premained nourceated. " "The results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 II you desire specific advice for your for in vitro diagnostic devices), please contact the and additionally 21 CLR Part 009110 103. Additionally, for questions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for question and (301) 504-4 Office of Comphance at (301) see contact the Office of Compliance at (301) 594-4639. advertising or your arregulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under llouiteanon (21CF ICPart 00197). Sales gold Manufacturers, International and the Act may be obtained from the Brumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Aliltrud
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name:
SleepBite
Indications For Use:
SleepBite is prescribed for the patient by the healthcare professional.
- A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
- B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Bite is indicated for ass in for obstructive sleep apnea.
- C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runsey
(Division Sign-Off) (Division Sign-on)
Division of Dental, Infection Control, and General Hospital Dexices ) - રજી 510(k) Number -
Prescription Use ?er 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)