(253 days)
Not Found
No
The description focuses on the material and physical properties of a night guard, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is intended for protection from teeth grinding, clenching, and bruxism, reducing damage to teeth and preventing associated noise. It does not claim to treat, cure, mitigate, or prevent any disease or condition of the body, which is the definition of a therapeutic device. Its function is protective and preventative of damage, not therapeutic.
No
Explanation: The device is described as a night guard intended to protect teeth from grinding and clenching. Its purpose is to prevent damage and reduce noise, not to diagnose a condition. It provides a physical barrier and protection rather than analyzing or identifying a disease or condition.
No
The device description explicitly states it is composed of a physical material (thermoplastic elastomers) and is a physical night guard, 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 from teeth grinding, clenching, and bruxism, and to reduce damage and noise associated with these actions. This is a mechanical or physical intervention applied to the teeth.
- Device Description: The device is a physical night guard made of a thermoplastic elastomer.
- Lack of Diagnostic Function: 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.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This night guard does not fit that description.
N/A
Intended Use / Indications for Use
The Stressgard™ Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.
Product codes
OBR
Device Description
The TotalGard™ Stressgard™ Night Guard is composed entirely of a soft, flexible semitransparent FDA compliant material, Monprene® thermoplastic elastomers. As packaged, the Stressgard ™ Night Guard is ready for use by the consumer. If desired, the Stressgard™ Night Guard is easily trimmed by the consumer, however it requires no forming or molding for use.
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
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 in support of this 510(k) Notification.
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
510 (K) SUMMARY TOTAL-GARD CORPORATION STRESSGARD "M NIGHT GUARD
510(K) NUMBER: _______________________________________________________________________________________________________________________________________________________________ JUL - 1 2008
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE OF PREPARATION
Total-Gard, Corporation 800 West Cummings Park Suite 1550 Woburn, MA 01801
I
Contact: Glenn Bancroft, Vice President
Telephone: 888.447.1807 Facsimile: 781.376.0638
OR
Bell & Izzi, LLC 70 West Foster Street Melrose, MA 02176
Contact: Louis P. Izzi, Esq.
Telephone: 781.665.3360 Facsimile: 781.665.1321
Date Prepared: October 17, 2007
II NAME OF DEVICE
Stressgard TM Night Guard
III NAME OF SPONSOR, ADDRESS, TELEPHONE NUMBER AND CONTACT PERSON
Total-Gard, Corporation 800 West Cummings Park Suite 1550 Woburn, MA 01801
Contact Person: Glenn Bancroft, Vice President
Telephone: 888.447.1807 Facsimile: 781.376.0638
1
510 (K) SUMMARY TOTAL-GARD CORPORATION STRESSGARD ™ NIGHT GUARD
510(K) NUMBER: 201
IV COMMON OR USUAL NAME
Dental Protector Nightguard
V PREDICATE DEVICES
Dental Concepts, LLC, The Doctor's® Nightguard™ (K053580) Dentek Oral Care, Inc., Comfort Fit Nightguard (K072147) Splintek-Power Products, Inc., SleepRight® (K071404)
VI INTENDED USE/INDICATIONS FOR USE
The Stressgard™ Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.
VII TECHNOLOGICAL CHARACTERISTICS
The TotalGard™ Stressgard™ Night Guard is composed entirely of a soft, flexible semitransparent FDA compliant material, Monprene® thermoplastic elastomers. As packaged, the Stressgard ™ Night Guard is ready for use by the consumer. If desired, the Stressgard™ Night Guard is easily trimmed by the consumer, however it requires no forming or molding for use.
VIII PERFORMANCE DATA
No performance data is required in support of this 510(k) Notification.
IX SUBSTANTIAL EQUIVALENCE
The TotalGard™ Stressgard™ Night Guard is as safe and effective as the predicate devices. With respect to the physical composition of the Stressgard™ Night Guard, not unlike the predicate devices, the Stressgard™ Night Guard is comprised of FDA compliant Monprene® which has been determined to be safe and effective for use in FDA cleared medical devices. The Stressgard™ Night Guard has similar intended uses and indications as the predicate devices and the labeling and instructions are appropriate for over the counter use. As a result, the TotalGard™ Stressgard™ Night Guard is substantially equivalent to the predicate devices with respect to safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 2008
TotalGard Corporation C/O Mr. Louis P. Izzi Bell & Izzi, LLC 70 West Foster Street Melrose, Massachusetts 02176
Re: K072968
Trade/Device Name: Stressgard™ Night Guard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: May 22, 2008 Received: May 23, 2008
Dear Mr. Izzi:
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
Pagc 2 - Mr. Izzi
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.
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, "Misbranding 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clare
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
510(k) Number (if known): ______________________
Device Name: Stressgard™ Night Guard
Indications For Use:
The Stressgard™ Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Setz DDS for Dr. Susan Renner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072968
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