Who is the manufacturer of CustMBite Dental Guard?

Dental Choice Holdings, LLC filed the 510(k) submission for CustMBite Dental Guard (K183315).

What is the FDA product code for CustMBite Dental Guard?

OBR. as a Class U device in the DE panel.

What is the regulatory pathway for CustMBite Dental Guard?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CustMBite Dental Guard?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CustMBite Dental Guard

Q: What are the predicate devices for CustMBite Dental Guard?

Oral-B plus Scope Outlast Nighttime Dental Guard (K113326).

K183315 · Dental Choice Holdings, LLC · OBR · Aug 23, 2019 · DE

Device Facts

Record ID	K183315
Device Name	CustMBite Dental Guard
Applicant	Dental Choice Holdings, LLC
Product Code	OBR · DE
Decision Date	Aug 23, 2019
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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.

Device Story

Over-the-counter dental guard; provides intraoral barrier against bruxism; used by patients during sleep. Device utilizes boil-and-bite customization technique to adapt to individual oral tissue contours. Patient self-fits device; cleans via toothbrush, toothpaste, and cold water. Acts as mechanical buffer to reduce tooth damage and grinding noise. Single-patient, reusable device.

Clinical Evidence

No clinical data; bench testing only. Biocompatibility testing conducted in accordance with ISO 10993-1, 10993-3, 10993-10, 10993-11, and 10993-12.

Technological Characteristics

Propylene-based elastomer material; heat-and-bite self-fit molding; non-sterile; reusable; single-patient use. Biocompatibility testing per ISO 10993 series.

Indications for Use

Indicated for adults 18+ for protection against bruxism (nighttime clenching/grinding) to reduce tooth damage and noise.

Regulatory Classification

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Predicate Devices

Oral-B plus Scope Outlast Nighttime Dental Guard (K113326)

Related Devices

K061122 — NIGHT GUARD · Alpine Oral Care, LLC · Mar 12, 2007
K210011 — JS Dental Lab Mouth Guard · Ampower Dental Laboratories, LLC · Jul 16, 2021
K132469 — THE BITE GUARD · International Profit Builders, Inc. · Feb 28, 2014
K240810 — Anti Grinding Guard · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 24, 2024
K172452 — Bruxor · Sleep Specialties, LLC · Jan 11, 2018

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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).