(22 days)
No
The device description and performance studies focus on material properties, fitting methods, and user satisfaction, with no mention of AI or ML.
Yes
The device is intended to prevent or reduce damage to teeth from bruxism or grinding, which is a therapeutic purpose.
No
The device is described as a "Dental Protector" or "nightguard" used to prevent damage from bruxism or teeth grinding. Its intended use is to reduce damage and prevent noise associated with grinding, not to diagnose a condition.
No
The device description clearly states it is a "fully occlusive nightguard" and describes physical modifications to the device, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for protection against bruxism and nighttime teeth grinding, reducing damage to teeth and preventing noise. This is a physical intervention for a physiological condition.
- Device Description: The device is a physical nightguard fitted to the patient's mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo (within the body) as a physical barrier and protector.
N/A
Intended Use / Indications for Use
The Rest Assured III is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Product codes
OBR
Device Description
The Rest Assured Generation III is the same device as Ranir's Rest Assured Generation II with the following minor differences: a reduction in the overall mass of the device, slight increase in arc width, additional impression material and base material, removal of sidewall material, addition of a small triangle fitting notch, and limited labeling changes.
The Rest Assured III is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth, gingiva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
User (patient) / At home (implied by "boil and bite" method and "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
A user study was conducted to verify that the modifications to the device provided increased flexibility and ease in the fitting process. Ninety percent (90%) of the participants were pleased with the overall fitting process and fit their device correctly.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis per ISO 14971.
Biocompatibility evaluation per ISO 7405.
Third party testing laboratory verified that the subject device is comparable to a legally marketed predicate device.
User study: 90% of participants were pleased with the overall fitting process and fit their device correctly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ranir, LLC's Rest Assured Generation II Dental Protector (K091792), DenTek Oral Care, Inc.'s Night Guard (K063483)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters, specifically 'K120103'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The writing appears to be done with a dark ink or marker on a light background.
FEB --3 2012
510(k) SUMMARY
Ranir, LLC's Rest Assured Generation III Dental Protector
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Gerard J. Prud'homme Regulatory Counsel to Ranir, LLC Hogan Lovells US LLP 555 Thirteenth Street, N.W. Washington, DC 20004
(202) 637-5735 Phone: (202) 637-5910 Facsimile:
Date Prepared: January 12, 2012
Name of Device and Name/Address of Sponsor
Rest Assured Generation III Dental Protector
で
Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512 Phone: (616) 698-8880 (616) 656-7650 Facsimile:
Common or Usual Name
Nightguard
Classification Name
Mouthguard, Over-the-Counter
Classification Product Code
OBR
1
Predicate Devices
Ranir, LLC's Rest Assured Generation II Dental Protector (K091792) DenTek Oral Care, Inc.'s Night Guard (K063483)
Purpose of the Special 510(k) Notice
The Rest Assured Generation III is a modification to Ranir's Rest Assured Generation II Dental Protector (K091792).
The Rest Assured Generation III is the same device as Ranir's Rest Assured Generation II with the following minor differences: a reduction in the overall mass of the device, slight increase in arc width, additional impression material and base material, removal of sidewall material, addition of a small triangle fitting notch, and limited labeling changes.
Intended Use
The Rest Assured III is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Technological Characteristics
The Rest Assured III is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method. Similarly, the predicate devices are fully occlusive nightguards fitted by the "boil and bite method"; therefore, the Rest Assured III is technologically similar to the predicate devices.
Substantial Equivalence
FDA cleared the claimed predicate devices, the Rest Assured II (K091792) and the DenTek NightGuard (K063483), for the reduction of damage to the teeth and the prevention of the noise associated with bruxing or grinding. In other words, the Rest Assured III has the same indications for use as the Rest Assured II and the DenTek NightGuard.
ﮯ
The Rest Assured III has very similar technological characteristics as the Rest Assured II, to which it is a modification, and to the DenTek NightGuard. All three devices are fully occlusive nightguards, which contain a hard occlusal base tray, overlaid with a softer, occlusal layer which contacts the patient's teeth and gingiva. In addition, the three devices are custom fitted by the user by the "boil and bite" method.
2
In sum, the Rest Assured III is as safe and effective as the predicate devices. The Rest Assured III has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Rest Assured III and the predicate devices raise no new questions of safety or effectiveness. Thus, the Rest Assured III is substantially equivalent.
Performance Testing
A risk analysis for the subject device was performed per ISO 14971 and ISO 7405 was adhered to in the evaluation of biocompatibility of device materials.
In addition, a third party testing laboratory tested the device to establish that the subject device is comparable to a legally marketed device. The third party laboratory verified that the subject device is comparable to a legally marketed predicate device.
Lastly, a user study was conducted to verify that the modifications to the device provided increased flexibility and ease in the fitting process. Ninety percent (90%) of the participants were pleased with the overall fitting process and fit their device correctly.
In sum, the above summarized testing confirm that the Rest Assured Generation III is substantially equivalent to the claimed predicate devices in intended use, device design, and principles of operation.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 3 2012
Ranir, LLC C/O Mr. Gerard J. Prud'homme Regulatory Counsel to Ranir, LLC Hogan Lovells US LLP 555 Thirteenth Street, N.W. Washington, DC 20004
Re: K120103
Trade/Device Name: Rest Assured Generation III Dental Protector Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: January 12, 2012 Received: January 12, 2012
Dear Mr. Prud'homme:
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 (1 will ); it may of babyer. Casino f Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 – Mr. Prud'homme
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.htm 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,
hp 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
5
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Rest Assured Generation III Dental Protector
Indications for Use:
The Rest Assured Generation III Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Prescription Use (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use X (Per 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)
Swen Runge
(Division Sign-Off)
al Choich Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices and Station of Anesthesiology, Gene
Infection Control, Dental Devices
510(k) Number: K120603