REST ASSURED GENERATION II DENTAL PROTECTOR

K091792 · Ranir Corporation · OBR · Jul 8, 2009 · DE

Device Facts

• Record ID: K091792
• Device Name: REST ASSURED GENERATION II DENTAL PROTECTOR
• Applicant: Ranir Corporation
• Product Code: OBR · DE
• Decision Date: Jul 8, 2009
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Rest Assured Generation II Dental Protector 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

Rest Assured Generation II Dental Protector is an over-the-counter, fully occlusive nightguard; used by patients at home to manage bruxism; fitted via 'boil and bite' method; acts as physical barrier to reduce tooth damage and grinding noise; modification of previous generation device.

Technological Characteristics

Fully occlusive nightguard; 'boil and bite' thermoplastic fitting method; mechanical barrier.

Indications for Use

Indicated for individuals requiring protection against bruxism or nighttime teeth grinding to reduce dental 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

• Rest Assured Night Protector (K063229)
• Doctor's Nightguard Advanced Comfort Fit (K073220)

Submission Summary (Full Text)

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

K091792

### 510(k) SUMMARY

# Ranir, LLC's Rest Assured Generation II Dental Protector

# 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: June 16, 2009

## Name of Device and Name/Address of Sponsor

Rest Assured Generation II Dental Protector

Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512 Phone: [phone] Facsimile: [phone]

#### Common or Usual Name

Nightguard

#### Classification Name

Mouthguard, Over-the-Counter

#### Classification Product Code

OBR

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

## Predicate Devices

Ranir, LLC's Rest Assured Night Protector (K063229) Prestige Brands, Inc.'s Doctor's Nightguard Advanced Comfort Fit (K073220)

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

The Rest Assured Generation II is a modification to Ranir's Rest Assured Night Protector (K063229).

## Intended Use

The Rest Assured 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

The Rest Assured II is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method. Similarly, the predicate devices are fully occlusive nightguards fitted by the "boil and bite method"; therefore, the Rest Assured II is technologically similar to the predicate devices.

### Substantial Equivalence

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

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL - 8 2009

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

Re: K091792

Trade/Device Name: Rest Assured Generation II Dental Protector Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: June 16, 2009 Received: June 17, 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/

CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Purres

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

Enclosure

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

K091792

## Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Rest Assured Generation II Dental Protector

Indications for Use:

The Rest Assured Generation II Dental Protector 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)

Rha Muly for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091792