THE BITE GUARD

K132469 · International Profit Builders, Inc. · OBR · Feb 28, 2014 · DE

Device Facts

• Record ID: K132469
• Device Name: THE BITE GUARD
• Applicant: International Profit Builders, Inc.
• Product Code: OBR · DE
• Decision Date: Feb 28, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Bite Guard" Is used To Prevent grinding of the teeth, jaw clenching and to reduce damage to feeth from grinding .

Device Story

The Bite Guard is a flexible, moldable dental protector; functions as a physical barrier between upper and lower teeth to prevent grinding and clenching. Device is constructed of a propylene-based elastomer/thermoplastic resin. User-operated via "boil and bite" method: device is submerged in boiling water to soften, then molded to the patient's dental arch. Intended for OTC use; patient self-fits. Cleaning performed with mouthwash or toothpaste. Provides protective barrier during sleep to reduce dental damage. No clinical data; relies on biocompatibility testing.

Clinical Evidence

No clinical tests performed. Evidence based on non-clinical biocompatibility testing and comparison to predicate devices. Predicate devices established safety profile for this class of OTC mouth guards.

Technological Characteristics

Occlusive night guard; boil-and-bite molding. Materials: Propylene-based elastomer and thermoplastic resin. Non-flavored, no color additives. Manufacturing: Injection mold. Single-patient, reusable. Dimensions identical to standard OTC mouth guards.

Indications for Use

Indicated for individuals who grind their teeth or clench their jaw to prevent tooth grinding, reduce jaw clenching, and minimize damage to teeth.

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

• Ranir, LLC's Rest Assured Generation III Dental Protector (K091792)
• Dentek's Comfort Fit Night guard (K072147)
• Oral B plus Outlast Nighttime Dental Guard (K113326)

Submission Summary (Full Text)

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# FEB 2 8 2014

Image /page/0/Picture/1 description: The image shows the logo for IPB Inc. The letters are in a bold, sans-serif font. The letters are all capitalized except for the "inc" which is in lowercase and slightly smaller than the other letters. The logo is simple and easy to read.

K132469

## 510(k) SUMMARY

International Profit Builders Inc. (IPB Inc.) "The Bite Guard"

## 1. Submitted by and Contact:

Bryan Tapocik CEO/President of International Profit Builders Inc. (IPB Inc.) 7045 Palm Avenue Highland, CA 92346 Tel: [phone] Fax: [phone]

Date Prepared: June 13, 2013

This Summary was amended on 12/03/2013 and any questions should be addressed to:

Bryan Tapocik 7045 Palm Avenue Highland, CA 92346 [phone]

#### 2. Name of Device and Name/ Address of Sponsor

#### "The Bite Guard"

International Profit Builders Inc. (IPB Inc.) 7045 Palm Avenue Highland, CA 92346

#### a. Common or Usual Name

Mouth guard

### b. Classification Name

Mouth guard, Over-the-Counter

#### c. Classification Product Code

OBR

#### 3. Predicate Devices and Biocompatibility

Ranir, LLC's Rest Assured Generation III Dental Protector (K091792) Dentek's Comfort Fit Night guard (K072147) Oral B plus Outlast Nighttime Dental Guard (K113326) Product code OBR- Our device is substantially equivalent to the above devices on the current market:

- a) Same Intended use
- b) Same technology
- c) Same device design
- Similar physical properties as Predicate Devices ರು)
- Similar materials e)
- () Same scientific concepts that form the basis of the device

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Image /page/1/Picture/0 description: The image shows the logo for IPB Inc. The letters "IPB" are in a bold, sans-serif font, with the "P" and "B" having a rounded top. To the right of "IPB" is the word "Inc", which is in a smaller, regular font. The logo is simple and professional.

## 4. Device Description

"The Bite Guard" is a flexible and moldable dental protector which is a comfortable mouth guard as a barrier between teeth for individuals who grind their teeth. Submerging the device into boiling water allows it to be molded to fit the patient's oral cavity exclusively. "The Bite Guard" is shaped like a dental arch and is constructed of a propylene-based elastomer.

## a. Indication of use

The Bite Guard is used to prevent grinding of the teeth, jaw clenching and to reduce damage to the teeth from grinding.

| Element of<br>Comparison | Subject Device<br>"The Bite Guard" | Predicate Device<br>Dentek's Comfort Fit<br>Night guard | Predicate Device<br>Oral B Plus Outlast<br>Nighttime Dental Guard |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 510 (k) - Number | K132469 | K072147 | K113326 |
| Device Description | Flexible, moldable<br>mouth guard used as a<br>barrier between teeth<br>for nighttime teeth<br>grinding. | Flexible, moldable<br>mouth guard used as a<br>barrier between teeth<br>for nighttime teeth<br>grinding. | Flexible, moldable Mouth<br>guard used for nighttime<br>teeth grinding. |
| Thermal Safety | Boil and Bite Method | Boil and Bite Method | Boil and Bite Method |
| Method of<br>Manufacturing | Injection Molded | Injection Molded | Injection Molded |
| RX or OTC | OTC | OTC | OTC |
| Reusable | Yes, Single Patient | Yes, Single Patient | Yes, Single Patient |
| Method of<br>Disinfection | Mouthwash or<br>Toothpaste to clean | Mouthwash or<br>Toothpaste to clean | Mouthwash or Toothpaste<br>to clean |
| Compatibility with<br>Environment Other<br>Devices | Biocompatible<br>Materials used | Biocompatible<br>Materials used | Biocompatible Materials<br>used |
| Indication of Use | Prevent teeth grinding<br>Reduces jaw clenching<br>and damage to the<br>teeth. | Protection Against<br>Night grinding to<br>reduce teeth damage. | Protection Against Night<br>grinding to reduce teeth<br>damage. |
| Flavored/Materials | No Flavor<br>Thermoplastic Resin<br>Propylene-Elastomer | No Flavor<br>Thermoplastic Resin | Yes<br>Soft Propylene -<br>Elastomer/thermoplastic |

## b. Comparison of Technical Characteristics of Predicate Devices - See Chart on page 26

c. Physical State

"The Bite Guard" in its physical state is composed of the following ingredients:

- Propylene-based Elastomer/Thermoplastic .
- . Non - Flavored/ No colored additives

This presents a soft propylene-based elastomer that can be moided to the individual's teeth.

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Image /page/2/Picture/0 description: The image shows the logo for IPB Inc. The letters "IPB" are in a bold, sans-serif font. The "B" is stylized with two horizontal lines running through it. To the right of the letters is the word "Inc" in a smaller, sans-serif font.

#### d. Scientific Concepts

"The Bite Guard" is based on the scientific concept of a physical barner placed between the individual's teeth while they sleep. The barner is intended to reduce damage to the upper and lower teeth make contact. This is a removable appliance that is fitted to the mouth by taking an impression of the teeth when in a heated state.

#### 5. Technological Characteristics of the Device

"The Bite Guard" is an occlusive night guard, fitted to the patient by the "boil and bite" method. The predicate devices are occlusive night guards as well, and also use the "boil and bite" method; therefore, The Bite Guard is technologically identical to the predicate devices. The overall shape and dimensions are identical with OTC mouth guards.

#### a. Materials

Thermoplastic Resin and Polypropylene based elastomer. When heated it fits to the individual's teeth. It is non-flavored with no color additives. In respect to indications for use and technology, the difference between the subject and Predicate Devices does not change the functional characteristics in any way.

#### b. Methods of Manufacturing

Injection mold

### 6. Clinical Tests Performed/ Bench

There were no clinical tests performed.

## Performance Data Test preformed on Predicate devices:

"The Bite Guard" relied on biocompatibility testing as the basis for non-clinical data. The testing performed on predicate devices the night guard is safe for individuals to use. "The Bite Guard" is non-flavored and has no color additives unlike its predicate Oral B plus Outlast Nighttime Dental Guard which are flavored but they have the same material, manufacturing processes, and chemical composition and sterilization methods. Attached you will find the flow chart for Biocompatibility of Toxicity test for the 501(k). Page 27

#### 7. Shelf Life of Device

18 months.

A nighttime mouth guard is a product that allows the consumer to provide a barner between their upper and lower teeth during periods in which they grind their teeth most, while asleep. The biocompatibility rationale is presented on page 26.

#### 10. Conclusion

"The Bite Guard" is substantially equivalent in safety and effectiveness, design, material and chemical composition to its predicate devices except flavor. It holds up against the other mouth guards in the industry as described above.

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#### 12 Inc

"The Bite Guard" has identical characteristics as the other devices, a soft, formable propylene-based elastomer/ thermoplastic resin that is fitted to individuals through the boil and bite method. The Device provides a protective barrier between the consumers' upper and lower teeth to prevent grinding.

"The Bite Guard" is substantially equivalent in safety and effectiveness to Dentek's Custom Fit Night guard (K072147) and Oral B plus Outlast Nighttime Dental Guard (K113326). Ranir LLC's Rest Assured (K091792).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The words are black against a white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## February 28, 2014

International Profit Builders Incorporated Mr. Bryan Tapocik CEO/President 7045 Palm Avenue Highland, CA 92346

K132469 Re

> Trade/Device Name: The Bite Guard Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: June 13, 2013 Received: December 9, 2013

Dear Mr. Tapocik:

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.

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Page 2 - Mr. Tapocik

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) (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -2014.02.28.14 -05'00":

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

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Indications for Use

K132469

510(k) Number (if known): 5495 Device Name: The Bite Guard Indications For Use:

The Bite Guard" Is used To Prevent grinding of the teeth, jaw clenching and to reduce damage to feeth from grinding .

ascription Use rt 21 CFR 801 Subman D AND/OR

Over-The-Counter Use 121 CFR 807 Subnart C

EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of Center for Devices and Radiological Health (CDRH)

Mary S. Runner

Susan Rupee 108 MA 2014.02.11

14:08:24-05'00'

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