(322 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components or capabilities. The device is a physical mouth guard.
Yes
The device is intended to reduce damage to teeth and prevent noise associated with bruxing and grinding, which are therapeutic benefits.
No
The device description and intended use state that the Night Guard is for protection against bruxism and teeth grinding by providing a barrier between teeth; it does not mention diagnosing any condition.
No
The device description clearly states it is a "soft, comfortable, mouth guard" which is a physical, hardware device.
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.
- Night Guard function: The Night Guard is a physical device that is placed in the mouth to provide a barrier between teeth. It does not analyze any biological samples from the body.
- Intended Use: The intended use clearly states its purpose is for physical protection against bruxism and teeth grinding, not for diagnosing any condition.
The information provided about the device description, anatomical site, intended user, and lack of performance studies related to biological samples further supports that it is not an IVD.
N/A
Intended Use / Indications for Use
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding.
Product codes (comma separated list FDA assigned to the subject device)
MQC
Device Description
NightGuard is a soft, comfortable, mouth guard intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably. NightGuard is a full coverage device which covers the occlusal surfaces of all the upper teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, oral
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)
No non-clinical tests were preformed for the determination of substantial equivalence.
No clinical tests were preformed for the determination of substantial equivalence.
No conclusions were drawn from Non-clinical and Clinical Test.
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.
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
510(k) Summary
[As Required by 21 CFR 807.92(c)]
MAR i 2 2007
1. Owner Information: [807.92(a)(1)]
Alpine Oral Care, LLC Owner's Name: . 4003 Leeland Ave Owner's Address: Houston, TX 77003 Telephone: (713) 223-8899 Fax: (713) 223-0982
Contact Person: Cathy Teng
Date Prepared: 02/15/07
2. Device Name: [807.92(a)(2)]
Trade Name: NightGuard
Common Name: mouth guard
Mouth guards have yet to be classified.* Classification:
*Predicate products are classified under the following: Mouth guard Device: Product Code: MQC Review Panel: Dental
3. Predicate Devices: [807.92(a)(3)]
| Device | Applicant | 510(k) | Decision Date |
|---|---|---|---|
| Doctor's Nightguard | Dental Concepts, LLC | K053580 | 03/03/06 |
| Ez Splint & Ez Splin | Power Products, Inc. | K022809 | 10/17/2003 |
| Dr. Hays Bite Guard | Inventive Resources, Inc. | K014079 | 02/22/2002 |
4. Device Description: [807.92(a)(4)]
1
NightGuard is a soft, comfortable, mouth guard intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably. NightGuard is a full coverage device which covers the occlusal surfaces of all the upper teeth.
5. Intended Use: [807.92(a)(5)]
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding
6. Comparison to Predicate Device: [807.92(a)(6)]
Narrative Comparison:
The Night Guard is composed of a soft thermoplastic resin. When the product is heated and cooled briefly the material can be molded to fit the upper teeth. The predicate devices, are the same or substantial equivalent in terms of design, material, chemical composition as outlined in the follow table.
| Feature | NightGuard | Doctor's
Night Guard | Ez Splint PM | Dr Hays
Bite Guard |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------|-----------------------|
| Indications
for Use | The Night Guard
is intended for
protection against
bruxism and
nighttime teeth
grinding. It is
intended to reduce
damage to teeth and
to prevent the noise
associated with
bruxing and grinding | Same | Same | Same |
| Design | Adjustable Pre-
formed oral device | Same | Same | Same |
| Materials | Thermoplastic Resin | Thermoplastic
Resin | Elvax strap,
polypropelene and
kraton bite pads | Lexan
&
Evax |
| Method of
Manufacture | Injection Molded | Same | Same | Dental
Laboratory |
Table: 3-1
2
| molded | ||||
|---|---|---|---|---|
| Prescription | ||||
| Device | No | Same | Yes | Yes |
| Reusable | Yes, single patient | Same | Same | Same |
| Method of | ||||
| Disinfection | Warm water, soap | |||
| and air dry | Same | Same | Same |
7. Non-Clinical Tests Performed [807.92(b)(1)]
No non-clinical tests were preformed for the determination of substantial equivalence.
8. Clinical Tests Preformed [807.92(b)(2)]
No clinical tests were preformed for the determination of substantial equivalence.
9. Conclusions Drawn From Non-Clinical and Clinical Tests [807.92(b)(3)]
No conclusions were drawn from Non-clinical and Clinical Test.
10. Conclusion
NightGuard is as safe, as effective, and performs as well as or better than the predicated device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cathy Teng Manager Alpine Oral Care, LLC 4003 Leeland Avenue Houston, Texas 77003
MAR 1 2 2007
Re: K061122
Trade/Device Name; Night Guard Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: February 23, 2007 Received: February 28, 2007
Dear Ms. Teng:
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.
4
Page 2 -Ms. Teng
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 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,
Chin Lin, Ph.D.
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
5
1122
1
Indications for Use
510(k) Number : K061122
Device Name: Night Guard
Indications for Use:
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the negations would with bruxing and grinding.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use xx AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Suser Riomer