GRIND NO MORE GENERATION II

K094020 · Ranir, LLC · OBR · Jan 25, 2010 · DE

Device Facts

• Record ID: K094020
• Device Name: GRIND NO MORE GENERATION II
• Applicant: Ranir, LLC
• Product Code: OBR · DE
• Decision Date: Jan 25, 2010
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Device Story

Grind No More Generation II is an over-the-counter mouthguard for nighttime use. Device consists of two molar bite plates and one anterior bite plate connected by a buccal retention band. Molar plates feature grooves with vertical positioners to engage tooth anatomy for retention. Device acts as a physical barrier between teeth to prevent damage and noise from bruxism. Used by patients at home without physician intervention.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Anterior and posterior occlusive mouthguard. Components: two molar bite plates, one anterior bite plate, buccal retention band. Molar plates include grooves with vertical positioners for retention. Non-electronic, mechanical device.

Indications for Use

Indicated for individuals experiencing bruxism or nighttime teeth grinding to protect teeth from damage and reduce grinding 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

• Grind No More 2 (K091175)
• Rest Assured Nite Protector (K063229)

Submission Summary (Full Text)

{0}------------------------------------------------

K09 4020

## 510(k) SUMMARY

### Ranir, LLC's Grind No More Generation II

JAN 2 5 2010

: |

# Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

Jonathan S. Kahan Regulatory Counsel to Ranir, LLC Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004

| Phone: | [phone] |
|------------|----------------|
| Facsimile: | [phone] |

Date Prepared: December 10, 2009

## Name of Device and Name/Address of Sponsor

Grind No More Generation II

Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512

[phone] Phone: Facsimile: [phone]

### Common or Usual Name

Mouthguard

#### Classification Name

Mouthguard, Over-the-Counter

#### Classification Product Code

OBR

{1}------------------------------------------------

#### Predicate Devices

Ranir, LLC's Grind No More 2 (K091175) Ranir, LLC's Rest Assured Nite Protector (K063229)

#### Purpose of the Special 510(k) notice.

The Grind No More Generation II is a modification to Ranir's Grind No More 2 (K091175).

#### Intended Use

Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

#### Technological Characteristics

Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate. However, there are multiple FDA cleared mouthguards that incorporate both anterior and posterior occlusion, such as the predicate Rest Assured. Therefore, the Grind No More Generation II is technologically similar to the predicate devices.

#### Substantial Equivalence

Grind No More Generation II is as safe and effective as the predicate devices. Grind No More Generation II has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Grind No More Generation II and the predicate devices raise no new questions of safety or effectiveness. Thus, the Grind No More Generation II is substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.

#### Public Health Service

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

JAN 9 5 2010

Ranir LLC C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan and Hartson LLP 555 Thirteenth Street, N.W. Washington, District of Columbia 20004

Re: K094020

Trade/Device Name: Grind No More Generation II Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: OBR Dated: December 29, 2009 Received: December 29, 2009

Dear Mr. Kahan:

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 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.

{3}------------------------------------------------

Page 2 - Mr. Kahan

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: Grind No More Generation II

Indications for Use:

The Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Prescription Use (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use X (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBetz DDS for Dr. K.P. Mulay

(Division Sign-Off) ( (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: