(55 days)
Not Found
No
The device description and intended use describe a physical, moldable mouthguard for bruxism, with no mention of software, algorithms, or any technology that would suggest AI/ML. The "Not Found" entries for AI/ML mentions, image processing, training/test sets, and performance studies further support this conclusion.
Yes
The device is indicated for protection against bruxism or night time teeth grinding, and is intended to reduce damage to teeth and prevent associated noise, which are therapeutic benefits.
No
The device is intended for protection against bruxism and teeth grinding, not for diagnosing bruxism or any other condition. Its purpose is to physically reduce damage to teeth and prevent noise associated with grinding, not to detect, monitor, or assess a medical condition.
No
The device description explicitly states it is composed of physical components (moldable soft upper component and a hard temporary fitting tray) made of thermoplastic resin and Santoprene™.
No, 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 Rest Assured™ Nite Protector is a physical device that is placed in the mouth to protect teeth from grinding. It does not analyze any biological samples or provide diagnostic information about a person's health.
- Intended Use: The intended use is for protection against bruxism and reducing associated damage and noise, not for diagnosing bruxism or any other condition.
The information provided clearly describes a physical medical device used for a protective and preventative purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Rest Assured™ Nite Protector is indicated for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
The Rest Assured™ Nite Protector, as packaged, is initially composed of two components: (1) a moldable soft upper component made of Elvax® thermoplastic resin and (2) a hard temporary fitting tray made of biocompatible medical grade Santoprene™ When heated and cooled, the upper Elvax® portion of the mouthguard may be molded to fit the consumer's upper teeth. During the brief fitting process, the Santoprene™ temporary fitting tray maintains the shape of the upper material and prevents the user from biting through the upper material. After the desired fit is achieved, the temporary fitting tray is removed and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
No performance data is required for this 510(k) notice.
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.
K053580, K024261, K014079, K022809
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
K06.3229
510(K) SUMMARY
Ranir Rest Assured™ Nite Protector
DEC 1 9 2006
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Preparer's Name, Address, Telephone Number, Contact Person, Date of 1. Preparation
Warner Norcross & Judd LLP 900 Fifth Third Center 111 Lyon Street N.W. Grand Rapids, Michigan 49503
Christopher J. Predko Contact: Telephone: (616) 752-2190 Fax: (616) 222-2190
Date Prepared: October 24, 2006
2. Owner Name, Address, Telephone Number, Fax Number
Ranir LLC 4701 East Paris Avenue Grand Rapids, Michigan 49512
Telephone: (616) 698-8880 (616) 698-0820 Fax:
Name of the Device 3.
Rest Assured™ Nite Protector
4. Common or Usual Name
Dental Protector/Dental Mouthguard
Classification Name ડ.
Unclassified
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6. Predicate Devices
K053580, Dental Concepts LLC, Doctors® Night Guard™ K024261, Dental Concepts LLC, Bite Plate K014079, Inventive Resources, Inc., Dr. Hayes Bite Guard K022809, Power Products, Inc .- Splintek, EZ Splint
7. Intended Use
The Rest Assured™ Nite Protector is indicated for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding.
8. Device Description/Technological Characteristics
The Rest Assured™ Nite Protector, as packaged, is initially composed of two components: (1) a moldable soft upper component made of Elvax® thermoplastic resin and (2) a hard temporary fitting tray made of biocompatible medical grade Santoprene™ When heated and cooled, the upper Elvax® portion of the mouthguard may be molded to fit the consumer's upper teeth. During the brief fitting process, the Santoprene™ temporary fitting tray maintains the shape of the upper material and prevents the user from biting through the upper material. After the desired fit is achieved, the temporary fitting tray is removed and discarded.
9. Performance Data
No performance data is required for this 510(k) notice.
10. Comparison to Predicates/Substantial Equivalence Conclusion
The Rest Assured™ Nite Protector is as safe and effective as the predicate devices. With respect to physical makeup, the primary (upper) component of the Nite Protector, like the primary components of all four predicate devices, is made of Elvax®, a formable clear thermoplastic copolymer resin. As with the predicates, when heated and briefly cooled, the upper component can be molded to fit the upper teeth. The Nite Protector's secondary base component (the temporary fitting tray) is made of biocompatible medical grade Santoprene™, which has also been determined to be safe and effective for use in FDA cleared medical devices. The Nite Protector has similar intended uses and indications as the predicate devices. Like the Doctor's NightGuard product, the Nite Protector will be available over the counter and contains appropriate labeling and instructions for OTC use. Accordingly, the Rest Assured™ Nite Protector is substantially equivalent to predicate devices with respect to safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2013
Ranir, Limited Liability Company C/O Mr. Christopher Predko Attorney Warner Norcross & Judd, Limited Liability Partnership 900 Fifth Third Center 111 Lyon Street, North West GRAND RAPIDS MI 49503
Re: K063229
Trade/Device Name: Ranir-Rest Assured"M Nite Protector Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: OBR Dated: October 24, 2006 Received: October 25, 2006
Dear Mr. Predko:
This letter corrects our substantially equivalent letter of December 19, 2006.
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.
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Page 2 - Mr. Predko
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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours.
Susan Runner DDS, MA Mary S.
Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page __ |_ of _ |___
Indications for Use Statement
510(k) Number if known:_______________________________________________________________________________________________________________________________________________________
Ranir - Rest Assured™ Nite Protector Device Name:
Indications for Use:
The Rest Assured™ Nite Protector is indicated for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use _X (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division-Office) | |
|---|---|
| of Anesthesiology, General Hospital, | |
| on Control, Dental Devices | |
| Number: | K063229 |
1319073