(98 days)
Not Found
No
The 510(k) summary describes a mechanical device with no mention of software, data processing, or AI/ML terms.
Yes
The device is indicated for the "protection against bruxism or night time teeth grinding" and "to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding," which are therapeutic purposes.
No
The device is a protector intended to reduce damage and noise from bruxism, not to diagnose the condition.
No
The device description clearly states it is an "adjustable protector" and "provides a barrier between the upper and lower posterior teeth," indicating a physical, hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SleepRight® Original is a physical device worn in the mouth to protect teeth from grinding. It does not analyze any biological samples.
- Intended Use: The intended use is for physical protection against bruxism and reducing associated damage and noise. This is a mechanical function, not a diagnostic one.
Therefore, the SleepRight® Original falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SleepRight® Original is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 5 adjustments for the bite pads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
N/A
0
II. 510(k) Summary
JUN - 4 2010
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
Dr. T. J. Brown
General Information:
| A. Submitted By: | Splintek, Inc.
3325 Wyoming St
Kansas City, MO 64111
Tel: 816-531-2008
Fax: 816-531-1968 |
------------------ | ------------------------------------------------------------------------------------------------------ |
---|
Contact Person:
May 27, 2010 Date Prepared
- SleepRight® Original B. Device Trade Name:
Mouthguard Common Name:
Unclassified Classification Name:
SleepRight® -Low profile Predicate Devices: C.
Device Description: D.
An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 5 adjustments for the bite pads.
OTC Indications for Use: E.
The SleepRight® Original is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Cautions: Do not use if you are under 18 years of age; have TMJ; have teeth or jaw caint or if the dental guard is broken or damaged. Do not use as an athletic mouth pains, or it als tuse for more than 12 hours in a 24 hour period. Not for use with dentures, braces or other dental appliances. Do not use for more than 3 months dentifely bruces or built consulting your dentist. Ask a dentist before use if you have loose fillings, loose caps, or unfilled cavities; jaw clicking or pain, teeth pain, face pain; difficulty chewing; mouth sores; gum disease or bleeding gums; or serious respiratory problems. While using the product, see your dentist at least
1
20
every 6 months. Stop use and see a dentist if you develop loose teeth or a change in every o months. "We're ain or other irregularity; the product easily falls out of your your bit, experience pain or other welg bleeding gums, soreness, or other reaction inside your mouth.
| Element of Comparison | Subject Device
SleepRight® Original | Predicate
SleepRight® -Low profile |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K100545 | K071404 |
| Device Description: | An adjustable protector that
provides a barrier between
the upper and lower
posterior teeth. The
flexible connecting strap
provides 5 adjustments for
the bite pads. | An adjustable protector that
provides a barrier between the
upper and lower posterior
teeth. The flexible connecting
strap provides 4 adjustments
for articulating bite pads. |
| Physical Characteristics
Material | Elvax® strap,
Polypropylene bite pads | Elvax® strap, Polypropylene
and Kraton® bite pads |
| Thermal Safety | Same | Warm water (not boiling) is
recommended for fitting. |
| Method of Manufacture | Same | Injection Molded |
| Rx or OTC | OTC | Rx and OTC |
| Reusable | Same | Yes, single patient |
| Sterile | Same | No |
| Method of Disinfection | Same | Cool water, mouthwash or
toothpaste. |
| Design | Same except bite pads do
not articulate | Partial coverage, preformed
oral appliance with adjustable
bite pads. No boiling
required. |
| Compatibility with
Environment & Other
Devices | Same | Biocompatible materials used. |
| Indications for Use | Same | Protection against bruxism or
nighttime teeth grinding. It is
intended to reduce damage to
the teeth and to prevent the
noise associated with bruxing
or grinding. |
| OTC | Same | |
| Target Population | Same | Individuals over the age of 18
who clench and grind their
teeth. |
| Where used | Same | For home use. |
| Flavored | No | Yes |
- Comparison of Technical Characteristics to Predicate Device: F.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle-like emblem with three stylized shapes representing the human form. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 4 2010
Power-Products-Incorporated-Splintek · C/O Ms. Melaine Hasek Senior Regulatory Affairs Manager PRA International 9755 Ridge Drive Lenexa, Kansas 66219
Re: K100545
Trade/Device Name: SleepRight® Original Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: May 28, 2010 Received: June 1, 2010
Dear Ms. Hasek:
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. 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.
3
Page 2-Ms. Melanie Hasek
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
I. Indications for Use:
Indications for Use Form
510(k) Number (if known):
Device Name: SleepRight Original
Indications For Use [Over The Counter (OTC)]:
The SleepRight Original is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C) X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page_1_of_1_
510(k) Number: K100545
Splintek, Inc.
Page 2 of 11