(88 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called "SleepRight® -Select, SleepRight®-Low Profile and SleepRight®-Advance, SleepRight® - Low Profile Rx and SleepRight® - Advance Rx". It is a mouthguard/nightguard intended for protection against teeth grinding (bruxism) and jaw clenching, and for short-term pain relief from muscle spasms.
The document does not describe a study that establishes acceptance criteria and then proves the device meets those criteria. Instead, it describes a substantial equivalence determination, comparing the device to legally marketed predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This is irrelevant, as the device is not an AI-assisted diagnostic tool).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (This is irrelevant, as the device is not an algorithm).
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Key Information from the Document:
The document focuses on establishing substantial equivalence to existing predicate devices based on:
- Identical Indications for Use (OTC):
- Subject Device (SleepRight®): Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
- Predicate Device (Doctor's NightGuard): Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
- Similar Indications for Use (Rx):
- Subject Device (SleepRight® Rx): Protection against teeth grinding, bruxism & jaw clenching; Short-term pain relief from muscle spasm due to occlusal interference; Prevention of chronic tension and TMJ caused by chronic jaw clenching.
- Predicate Device (EZ Splint): Protection against teeth grinding, bruxism & jaw clenching; Short-term pain relief from muscle spasm due to occlusal interference; Prevention of chronic tension and TMJ caused by chronic jaw clenching.
- Physical Characteristics: Materials (Elvax® strap, Polyurethane/Pellethane bite pads for Advance; Polypropylene/Kraton® bite pads for Select/Low Profile) are compared to predicates.
- Method of Manufacture: Both are "Injection Molded" (same as predicates).
- Design: Shared similarities with the EZ Splint (partial coverage, preformed oral appliance with adjustable bite pads, no boiling required), distinguishing it from the Doctor's NightGuard (full coverage, boil and bite technology).
- Reusability: "Yes, single consumer" (same as predicates).
The FDA determined that the device is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. This determination is not based on performance data against acceptance criteria in the way a clinical trial for a novel drug or a new AI diagnostic algorithm would be. Instead, it relies on the similarities in indications, technological characteristics, and safety profiles to already cleared devices.
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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 StKansas City, MO 64111Tel: 816-531-2008Fax: 816-531-1968 |
|---|---|---|
| Contact Person: | Dr. T. J. Brown | |
| Date Prepared | July 25, 2007 | |
| B. | Device Trade Name: | SleepRight® -Select, SleepRight®-Low Profile andSleepRight®-Advance,SleepRight® - Low Profile Rx andSleepRight® - Advance Rx |
| Common Name: | Mouthguard/nightguard | |
| Classification Name: | Unclassified | |
| C. | Predicate Devices: | EZ Splint - Power Products / SplintekThe 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.
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- F. Comparison of Technical Characteristics to Predicate Device:
| Element ofComparison | Subject DeviceSleepRight® | PredicateEZ Splint | PredicateDoctor'sNightGuard |
|---|---|---|---|
| PhysicalCharacteristicsMaterialSelectLow Profile | SameSame | Elvax® strap,Polypropylene andKraton® bite pads | Elvax resin andElvaloy® |
| Advance | Elvax StrapPolyurethane andPellethane bite pads. | ||
| Method ofManufacture | 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 oralappliance withadjustable bite pads.No boiling required. | Full coverage ofupper arch.Uses boil and bitetechnology to adjustfit. |
| Indications forUse | Protection againstbruxism or nighttimeteeth grinding. It isintended to reducedamage to the teethand to prevent thenoise associated withbruxing or grinding. | Protection againstteeth grinding,bruxism & jawclenching.Short-term painrelief from musclespasm due toocclusal interference.For the prevention ofchronic tension andTMJ caused bychronic jawclenching of themandibular andmaxillary teeth bythe temporalismuscle. | Protection againstbruxism or nighttimeteeth grinding. It isintended to reducedamage to the teethand to prevent thenoise associated withbruxing or grinding. |
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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.
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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
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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
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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
N/A