NIGHT GUARD

K061122 · Alpine Oral Care, LLC · MQC · Mar 12, 2007 · DE

Device Facts

• Record ID: K061122
• Device Name: NIGHT GUARD
• Applicant: Alpine Oral Care, LLC
• Product Code: MQC · DE
• Decision Date: Mar 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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

Device Story

NightGuard is a soft, thermoplastic resin mouth guard; shaped like a dental arch; covers occlusal surfaces of upper teeth. Patient heats and cools device to mold it to teeth; provides physical barrier to prevent tooth-to-tooth contact during bruxism. Used by patients at home for nighttime wear. Reduces dental damage and noise associated with grinding. Over-the-counter device; no prescription required. Reusable by single patient; cleaned with warm water and soap.

Clinical Evidence

No clinical data provided; no non-clinical tests performed for the determination of substantial equivalence.

Technological Characteristics

Thermoplastic resin material; injection molded; pre-formed adjustable oral device; full coverage of upper occlusal surfaces; available in three sizes; manual molding via heat/cool process; non-sterile; reusable.

Indications for Use

Indicated for patients experiencing bruxism and nighttime teeth grinding to reduce dental damage and noise.

Predicate Devices

• Doctor's Nightguard (K053580)
• Ez Splint & Ez Splin (K022809)
• Dr. Hays Bite Guard (K014079)

Submission Summary (Full Text)

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K061122

## 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: [phone] Fax: [phone]

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)]

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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<br>Night Guard | Ez Splint PM | Dr Hays<br>Bite Guard |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------|-----------------------|
| Indications<br>for Use | The Night Guard<br>is intended for<br>protection against<br>bruxism and<br>nighttime teeth<br>grinding. It is<br>intended to reduce<br>damage to teeth and<br>to prevent the noise<br>associated with<br>bruxing and grinding | Same | Same | Same |
| Design | Adjustable Pre-<br>formed oral device | Same | Same | Same |
| Materials | Thermoplastic Resin | Thermoplastic<br>Resin | Elvax strap,<br>polypropelene and<br>kraton bite pads | Lexan<br>&<br>Evax |
| Method of<br>Manufacture | Injection Molded | Same | Same | Dental<br>Laboratory |

#### Table: 3-1

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| | | | | molded |
|---------------------------|---------------------------------|------|------|--------|
| Prescription<br>Device | No | Same | Yes | Yes |
| Reusable | Yes, single patient | Same | Same | Same |
| Method of<br>Disinfection | Warm water, soap<br>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.

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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# 1122

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## 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

K061122