(42 days)
Not Found
No
The description focuses on the physical characteristics and biocompatibility of a "boil and bite" nightguard, with no mention of AI or ML technology.
Yes
The device is intended to reduce damage to the teeth and prevent noise associated with bruxing or grinding, which are therapeutic claims.
No
Explanation: The device is intended for protection against bruxism and teeth grinding, and to reduce damage and noise associated with these conditions. It does not perform any diagnostic function such as identifying, confirming, or monitoring a disease or condition.
No
The device description explicitly states it is an "occlusive nightguard" fitted by the "boil and bite" method, indicating a physical, hardware-based device. The performance studies also focus on material biocompatibility and physical characteristics.
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 teeth grinding, reducing damage to teeth and preventing noise. This is a physical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as an occlusive nightguard fitted to the consumer. This is a physical appliance worn in the mouth.
- Lack of Diagnostic Activity: There is no mention of the device being used to diagnose a condition, analyze biological samples (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on biocompatibility, physical characteristics, workmanship, and structural integrity. These are typical evaluations for a physical medical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Rest Assured® Extra Comfort Nie 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 teeth grinding.
Product codes
OBR
Device Description
The Rest Assured Extra Comfort Nite Protector is indicated 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 teeth grinding.
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)
Ranir contracted with the North American Science Associates, Inc. ("NAMSA") to conduct comprehensive biocompatibility testing on the finished Rest Assured® Extra Comfort product, and NAMSA concluded that the combination of Elvax® and Elvaloy® used in the final Rest Assured® device demonstrated appropriate biocompatibility for its intended use and duration of exposure. This testing is similar and produced similar results as compared to the Gen II predicate device.
Comprehensive biocompatibility testing conducted by NAMSA was for cytotoxicity, oral mucosal irritation, acute systemic toxicity, sensitization, material mediated pyrogenicity, leachables / extractables characterization, systemic toxicity, and genotoxicity. It was found that the material combination is biocompatible for the intended use and anticipated duration of use, and there are no leachables / extractables that pose a safety risk.
The Rest Assured® Extra Comfort Nite Guard was compared to the Doctor's Advance Comfort Night Guard and evaluated for physical characteristics. workmanship, performance, and hazards by third party testing. Ranir's Rest Assured® Extra Comfort Nite Guard was found to be comparable to this predicate device.
Simulated wear testing, and boil and bite testing, was also conducted on the Rest Assured® Extra Comfort Nite Guard. These tests confirm that the modifications with respect to the predicate Gen II device do not impact structural integrity.
All verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K 133423 DEC 20 2013
Image /page/0/Picture/1 description: The image shows the word "Ranir." in a bold, sans-serif font. To the left of the word is a plus sign that is stylized to look like a four-pointed star. To the right of the word is a period.
4701 East Paris Avenue SE
Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820
Attachment 8
510(k) Summary
1
Image /page/1/Picture/1 description: The image shows the word "Ranir." in a bold, sans-serif font. To the left of the word is a plus sign. The plus sign is also in a bold font and is slightly larger than the letters in the word "Ranir."
DEC 2 0 2013
4701 East Paris Avenue SE Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820
510(k) SUMMARY Ranir, LLC's Rest Assured Extra Comfort Nite Protector Dental Protector
| Submitter's Name: | Ranir, LLC |
|---|---|
| Address: | 4701 East Paris Avenue SE |
| Grand Rapids, MI 49512 | |
| Telephone Number: | Phone: (616) 698-8880 ext. 1278 |
| Facsimile: (616) 222-0710 | |
| Contact Person: | Paula Bojsen, Global Regulatory Compliance Manager |
| Date Prepared: | October 30, 2013 |
2. Device Name:
| Proprietary or Trade Name: | Rest Assured® Extra Comfort Nite Protector (Model
BRX-220013)
[Private Labeler Name] Extra Comfort Nite (or
"Night") Protector
[Private Labeler Name] Nite (or “Night”) Protector
[Private Labeler Name] Dental Protector |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | |
| | |
| Common or Usual Name: | Dental protector
Nightguard |
| Classification Name: | Mouthguard, Over-the-Counter |
| Product Code: | OBR |
3. Predicate Devices:
| Ranir, LLC's Rest Assured® Ready to Wear Nite Protector | (K112879) |
|---|---|
| Ranir, LLC's Rest Assured® Generation II Dental Protector | (K091792) |
| Prestige Brand's The Doctor's Advanced Comfort Night Guard | (K073220) |
2
Image /page/2/Picture/0 description: The image shows the word "Ranir." to the right of a plus sign. The plus sign is bolded and black. The word "Ranir." is also bolded and black.
4701 East Paris Avenue SE Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820
4. Device Description
The Rest Assured Extra Comfort Nite Protector is indicated 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 teeth grinding.
5. Purpose of the Special 510(k) notice.
The Rest Assured® Extra Comfort Nite Protector is a modification to Ranir's Rest Assured® Generation II Night Protector (K091792).
6. Intended Use:
The Rest Assured® Extra Comfort Nite Protector is indicated for use for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
7. Technological Characteristics:
The Rest Assured® Extra Comfort Nite Guard is an occlusive nightguard. fitted to the consumer by the "boil and bite" method. Similarly, the predicate devices are occlusive nightguards fitted by the "boil and bite" method"; therefore, the Rest Assured® Extra Comfort Nite Guard is technologically similar to the predicate devices.
8. Performance Testing:
The Rest Assured® Extra Comfort Nite Guard complies with the following recognized consensus standards:
- . lSO 14971:2007, Medical devices - Application of risk management to medical devices
- ISO 7405:2008, Dentistry Evaluation of biocompatibility of medical devices . used in dentistry
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
- . ISO 10993-3:2003, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for . in vitro cytotoxicity
- . ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
3
Image /page/3/Picture/0 description: The image shows the word "Ranir" with a plus sign to the left of the word and a period to the right of the word. The word is written in a sans-serif font. The plus sign is made up of four lines that intersect in the middle. The period is small and round.
4701 East Paris Avenue SE Grand Rapids, MI 49512 U.S.A. Telephone 616-698-8880 Fax 616-698-0820
Ranir contracted with the North American Science Associates, Inc. ("NAMSA") to conduct comprehensive biocompatibility testing on the finished Rest Assured® Extra Comfort product, and NAMSA concluded that the combination of Elvax® and Elvaloy® used in the final Rest Assured® device demonstrated appropriate biocompatibility for its intended use and duration of exposure. This testing is similar and produced similar results as compared to the Gen II predicate device.
Comprehensive biocompatibility testing conducted by NAMSA was for cytotoxicity, oral mucosal irritation, acute systemic toxicity, sensitization, material mediated pyrogenicity, leachables / extractables characterization, systemic toxicity, and genotoxicity. It was found that the material combination is biocompatible for the intended use and anticipated duration of use, and there are no leachables / extractables that pose a safety risk.
The Rest Assured® Extra Comfort Nite Guard was compared to the Doctor's Advance Comfort Night Guard and evaluated for physical characteristics. workmanship, performance, and hazards by third party testing. Ranir's Rest Assured® Extra Comfort Nite Guard was found to be comparable to this predicate device.
Simulated wear testing, and boil and bite testing, was also conducted on the Rest Assured® Extra Comfort Nite Guard. These tests confirm that the modifications with respect to the predicate Gen II device do not impact structural integrity.
All verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.
9. Substantial Equivalence
The Rest Assured® Extra Comfort Nite Guard possesses the same indications for use, technological characteristics, and principles of operation as the predicate devices (the currently marketed Ranir, LLC's Rest Assured® Generation II Dental Protector (091792), Rest Assured® Ready to Wear Nite Protector (K112879), and The Doctor's Advanced Comfort Fit Nightguard (K073220). The minor technological differences between the Rest Assured® Extra Comfort Nite Protector and the predicate devices raise no new questions of safety or effectiveness. Thus, the Rest Assured® Extra Comfort Nite Protector is substantially equivalent. All materials used are in the predicate devices, in different mixtures/combinations.
4
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Ranir, LLC Ms. Paula Bojsen Global Regulatory Compliance Manager 4701 East Paris Avenue SE Grand Rapids, MI 49512
Re: K133423
Trade/Device Name: Rest Assured® Extra Comfort Nite Protector (Model BRX-220013) Regulation Number: Unclassified Regulation Name: Mouthguard Over-The-Counter Regulatory Class: Unclassified Product Code: OBR Dated: September 17, 2013 Received: September 20, 2013
Dear Ms. Bojsen:
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.
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
5
Page 2 - Ms. Bojsen
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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rest Assured® Extra Comfort Nite Protector
Indications for Use (Describe)
The Rest Assured® Extra Comfort Nie 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 teeth grinding.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
SE SERVICE OF COLLECTION FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR BOOM OF
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Mary S. Runner -S 2013.12.18 08:37:11 -05'00'
.. 이후 : 대
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
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