(88 days)
EZ Splint - Power Products / Splintek, The Doctor's® NightGuard - Dental Concepts, LLC
Not Found
No
The device description and intended use do not mention any AI or ML capabilities. The device is a physical, adjustable night guard.
Yes
The device is intended to provide short-term pain relief and prevention of chronic tension/TMJ, which are therapeutic claims.
No
The device is described as an "adjustable protector that provides a barrier between the upper and lower posterior teeth" and its indications for use are related to protection against teeth grinding, bruxism, jaw clenching, and pain relief. There is no mention of the device being used to identify, detect, or diagnose a 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 device described is a physical night guard intended to be worn in the mouth to protect against teeth grinding and jaw clenching. It acts as a physical barrier and does not involve testing biological samples.
- Intended Use: The stated intended uses are related to physical protection and pain relief from mechanical issues (bruxism, clenching, occlusal interference), not the diagnosis of a disease or condition through in vitro testing.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Prescription Indications for Use:
. Protection against teeth grinding, bruxism & jaw clenching.
. Short-term pain relief from muscle spasm due to occlusal interference. .
. For the prevention of chronic tension and TMJ caused by chronic jaw clenching of . the mandibular and maxillary teeth by the temporalis muscle.
OTC Indications for Use:
The SleepRight® adjustable night guard 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)
MQC and OBR
Device Description
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.
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
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.
EZ Splint - Power Products / Splintek, The Doctor's® NightGuard - Dental Concepts, LLC
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
AUG 17 2007 This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
General Information:
| A. | Submitted By: | Splintek - Power Products Inc.
3325 Wyoming St
Kansas City, MO 64111
Tel: 816-531-2008
Fax: 816-531-1968 |
|----|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Dr. T. J. Brown |
| | Date Prepared | July 25, 2007 |
| B. | Device Trade Name: | SleepRight® -Select, SleepRight®-Low Profile and
SleepRight®-Advance,
SleepRight® - Low Profile Rx and
SleepRight® - Advance Rx |
| | Common Name: | Mouthguard/nightguard |
| | Classification Name: | Unclassified |
| C. | Predicate Devices: | EZ Splint - Power Products / Splintek
The Doctor's® NightGuard - Dental Concepts, LLC |
D. Device Description:
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.
- E. Prescription Indications for Use:
- . Protection against teeth grinding, bruxism & jaw clenching.
- Short-term pain relief from muscle spasm due to occlusal interference. .
- For the prevention of chronic tension and TMJ caused by chronic jaw clenching of . the mandibular and maxillary teeth by the temporalis muscle.
OTC Indications for Use:
The SleepRight® adjustable night guard 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.
1
- F. Comparison of Technical Characteristics to Predicate Device:
| Element of
Comparison | Subject Device
SleepRight® | Predicate
EZ Splint | Predicate
Doctor's
NightGuard |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical
Characteristics
Material
Select
Low Profile | Same
Same | Elvax® strap,
Polypropylene and
Kraton® bite pads | Elvax resin and
Elvaloy® |
| Advance | Elvax Strap
Polyurethane and
Pellethane bite pads. | | |
| Method of
Manufacture | Same | Injection Molded | Injection Molded |
| Rx or OTC | N/A | Rx | OTC |
| Reusable | Same | Yes, single consumer | Yes, single consumer |
| Design | Same as EZ Splint | Partial coverage,
preformed oral
appliance with
adjustable bite pads.
No boiling required. | Full coverage of
upper arch.
Uses boil and bite
technology to adjust
fit. |
| Indications for
Use | 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. | Protection against
teeth grinding,
bruxism & jaw
clenching.
Short-term pain
relief from muscle
spasm due to
occlusal interference.
For the prevention of
chronic tension and
TMJ caused by
chronic jaw
clenching of the
mandibular and
maxillary teeth by
the temporalis
muscle. | 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. |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's stylized logo, which consists of three abstract human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2007
Splintek - Power Products C/O Ms. Melanie K. Hasek, RAC Senior Project Manager, Regulatory Affairs PRA International 9755 Ridge Drive Lenexa, Kansas 66219
Re: K071404
Trade/Device Name: SleepRight® - Select SleepRight® - Low Profile and SleepRight® - Advance SleepRight® - Low Profile Rx and SleepRight® - Advance Rx Regulation Number: Unclassified Regulation Name: Not Applicable Regulatory Class: Unclassified Product Code: MQC and OBR Dated: July 25, 2007 Received: July 27, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Mibranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
Page 1 of 1
510(k) Number (if known): K071404
Device Name: SleepRight® - Low Profile Rx and SleepRight® - Advance Rx
Indications For Use (Rx):
- Protection against teeth grinding, bruxism and jaw clenching .
- Short-term pain relief from muscle spasm due to occlusal interference. .
- For the prevention of chronic tension and temporomandibular joint (TMJ) . syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Runne
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071404
5
I. Indications for Use:
Indications for Use Form
Page 1 of 1
510(k) Number (if known): ★071404
Device Name: SleepRight® - Select, SleepRight® - Low Profile and SleepRight® - Advance
Indications For Use (OTC):
The SleepRight® adjustable night guard 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 X
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Runco
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC71404