(266 days)
Not Found
No
The summary describes a physical dental guard that is customized using a boil and bite technique. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for protection against bruxism and to reduce damage to teeth, which are therapeutic purposes.
No
Explanation: The device is indicated for protection against bruxism and reducing damage to teeth, not for diagnosing a condition.
No
The device description clearly states it is a physical dental guard that is customized using a boil and bite technique, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- CustMBite Dental Guard Function: The CustMBite Dental Guard is a physical device worn inside the mouth to protect teeth from grinding. It does not analyze any biological specimens or provide diagnostic information about a person's health condition.
The provided information clearly describes a physical dental appliance for mechanical protection, not a diagnostic test.
N/A
Intended Use / Indications for Use
The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
The CustMBite Dental Guard is intended for individuals age 18 and older.
Product codes (comma separated list FDA assigned to the subject device)
OBR
Device Description
CustMbite Dental Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The CustMbite Dental Guard is intended to be worn while sleeping (e.g., at night or while napping). Through the process of customization using a boil and bite technique, the device fits an individual mouth adapting to a given person's oral tissue contours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral
Indicated Patient Age Range
18 and older
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 clinical study was conducted.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2019
Dental Choice Holdings, LLC % E.J. Smith, Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114
Re: K183315
Trade/Device Name: CustMBite Dental Guard Regulatory Class: Unclassified Product Code: OBR Dated: July 24, 2019 Received: July 25, 2019
Dear E.J. Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 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)
1
(21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183315
Device Name CustMBite Dental Guard
Indications for Use (Describe)
The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
The CustMBite Dental Guard is intended for individuals age 18 and older.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter: | Dental Choice Holdings, LLC |
|---|---|
| Address: | 10100 Linn Station Road |
| Louisville, KY 40223 | |
| Contact Person: | Ron Story |
| Vice President and Chief Information Officer | |
| Telephone Number: | 502-736-4600 |
| Email: | Ron.Story@deltadentalky.com |
Summary Preparation Date: August 21, 2019
| Device Description | |
|---|---|
| Trade Name: | CustMbite Dental Guard |
| Common Name: | Mouthguard, over-the-counter |
| Regulatory Class: | |
| Product Code: | OBR |
| C.F.R. Section: | Unclassified |
Predicate Device:
| Brand Name | 510(k) Number |
|---|---|
| Oral-B plus Scope Outlast Nighttime Dental Guard | K113326 |
Device Description
CustMbite Dental Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The CustMbite Dental Guard is intended to be worn while sleeping (e.g., at night or while napping). Through the process of customization using a boil and bite technique, the device fits an individual mouth adapting to a given person's oral tissue contours.
4
Indications for Use
The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism – the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.
The CustMBite Dental Guard is intended for individuals age 18 and older.
| Parameters | Dental Choice
Holdings, LLC
CustMBite Dental
Guard | Predicate Device
Oral-B plus Scope
Outlast Nighttime
Dental Guard | Similarities and
Differences |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Product Code | OBR | OBR | Similar |
| Product Classification | Unclassified | Unclassified | Similar |
| Classification Name | Mouthguard, OTC | Mouthguard, OTC | Similar |
| Indications for Use | The CustMBite Dental
Guard is an over-the-
counter dental guard
indicated for the
protection against
bruxism - the
nighttime clenching
and grinding of the
teeth.
It is intended for use in
the mouth at night to
reduce damage to the
teeth and to prevent
the noise associated
with teeth grinding.
The CustMBite Dental
Guard is intended for
individuals age 18 and
older. | The Oral B plus Scope
Outlast Nighttime
Dental Guard is an
over-the-counter
dental guard indicated
for the protection
against bruxism - the
nighttime clenching
and grinding of the
teeth.
It is intended for use in
the mouth at night to
reduce damage to the
teeth and to prevent
the noise associated
teeth grinding. | Similar |
| Intended Use | Aids in the reduction
of tooth damage and
noise due to bruxing
and grinding | Aids in the reduction
of tooth damage and
noise due to bruxing
and grinding | Similar |
| Anatomical Site and
Type of Use | Intraoral, during
sleep | Intraoral, during
sleep | Similar |
| Parameters | Dental Choice
Holdings, LLC
CustMBite Dental
Guard | Predicate Device
Oral-B plus Scope
Outlast Nighttime
Dental Guard | Similarities and
Differences |
| Materials | Propylene-based
elastomer | Propylene-based
elastomer and flavor | CustMBite does not
contain a flavor |
| Molding Method | Heat & Bite Self-fit | Heat & Bite Self-fit | Similar |
| Fit | One size fits all via
traditional heat
and bite | One size fits all via
traditional heat
and bite | Similar |
| Reusable | Yes
Single Patient | Yes
Single Patient | Similar |
| Biocompatibility | Biocompatibility
testing conducted in
accordance ISO
10993-1 | Biocompatibility
testing conducted in
accordance ISO
10993-1 | Similar |
| Sterility | Non-sterile | Non-sterile | Similar |
| Compatibility with
the Environment &
Other Devices | Label warnings
against use with
certain other dental
accessories | Label warnings
against use with
certain other dental
accessories | Similar |
| Cleaning | Scrub with
toothbrush,
toothpaste and cold
water | Scrub with
toothbrush,
toothpaste and cold
water | Similar |
Substantial Equivalence Discussion
5
Discussion of Technological Differences
-
a. Similarities:
The CustMbite Dental Guard has the following similarities to the predicate device: indications for use, intended use, anatomical site, material, molding method, customized fit., reusable, non-sterile, biocompatibility, cleaning and label warning. -
b. Differences:
The predicate device offers flavors for the dental guard and the CustMbite Dental Guard offers no flavors.
Non-Clinical Testing
6
- ISO 14971 Second edition 2007-03-01 Medical devices Application of risk . management to medical devices
- . ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
- ANSI/AAMI/ISO 10993-3:2014. Biological Evaluation of Medical Devices--Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ANSI/AAMI/ISO 10993-12: 2012. Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
- ISO 10993-10, 2010, Biological Evaluation of Medical Devices - Part 10: Tests for
- Irritation and Skin Sensitization ●
- ISO/IEC 17025, 2017, General Requirements for the Competence of Testing and
- Calibration Laboratories
- ISO 10993-11, 2017, Biological Evaluation of Medical Devices Part 11: Tests for . Systemic Toxicity
Clinical Testing
No clinical study was conducted.
Conclusion
Based upon similarities in indications for use, materials and principle of operation together with performance testing, we find that CustMbite Dental Guard to be substantially equivalent to Oral B plus Scope Outlast Nighttime Dental Guard (K113326).