EZ SPLINT & EZ SPLINT PM

K022809 · Power Products, Inc.-Splintek · MQC · Oct 17, 2003 · DE

Device Facts

• Record ID: K022809
• Device Name: EZ SPLINT & EZ SPLINT PM
• Applicant: Power Products, Inc.-Splintek
• Product Code: MQC · DE
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth.

Device Story

Oral occlusal appliance; used for bruxism, teeth-grinding, and jaw clenching management. Device consists of thermal-sensitive Elvax strap, polypropylene, and Kraton bite pads; injection-molded construction. EZ-Splint PM features anatomically contoured shape for cheek retention/stability during sleep; EZ-Splint features narrow shape for daytime use/speech flexibility. Patient-adjusted bite pads prevent posterior tooth contact; provides resilient break in clenching cycle. Prescription device; single-patient use; cleaned with warm water, soap, and toothbrush. Benefits include reduction of muscle tension and TMJ syndrome symptoms.

Clinical Evidence

No clinical data provided; no clinical tests performed.

Technological Characteristics

Materials: Elvax strap, polypropylene, Kraton bite pads. Design: Adjustable, pre-formed oral appliance. Manufacturing: Injection molded. Connectivity: None. Energy source: None (mechanical). Sterilization: Not specified (cleaned by user with soap/water).

Indications for Use

Indicated for patients requiring protection against teeth grinding, bruxism, and jaw clenching; short-term pain relief from muscle spasms due to occlusal interference; and prevention of chronic tension and TMJ syndrome caused by chronic jaw clenching.

Predicate Devices

• Dr. Hays Bite Guard (K104029)
• NTI Tension Suppression System (K010876)

Submission Summary (Full Text)

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# OCT 1 7 2003

### Attachment 4 Revised 7/16/03

#### 510(K) SUMMARY

Thi: summary of 510(k) safety and effectiveness information is being submitted in acc rdance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is K022809

#### 1. Submitter's Identification:

Power Products, Inc. - Splintek 3325 Wyoming Street Kansas City, Missouri 64111 Phone: [phone]

- Carolann Kotula Contact Person: Official Correspondent for PPI-Splintek mdi Consultants, Inc. 55 Northern Blvd. Suite 410 Great Neck, NY 11021 Phone: [phone] Fax: Alternate Phone: [phone] Alternate Fax: [phone] Email: [e-mail]
Date Summary Prepared: August 6, 2002

#### Name of the Device: 2.

Classification Name: Device, Jaw Repositioning

Common Name: Oral Occlusal Appliance or splint

Proprietary Name : EZ Splint and EZ Splint PM

Classification/Panel: These devices have not been classified. The Dental device panel will review this submission. The product code that has been assigned is LQZ.

- ని. Predicate Device Information: These devices are substantially equivalent in design and intended use to the Dr. Hays Bite Guard, K104029, as well as the NTI Tension Suppression System, K010876. Both predicates are used by the patient

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to assist in the treatment and management of bruxism, teeth-grinding, and associated mandibular muscle tension and pain.

- Device Description: The devices are constructed of a thermal sensitive Elvax 4. strap and polypropylene and Kraton® bite pads. The bite pads may be adjusted for the individual patient. Although the two products look similar, the EZ-Splint, PM has an anatomically contoured shape for maximum cheek retention and stability during sleep. The EZ-Splint was designed as small as possible for speech and maximum flexibility when used in conjunction with dental and orthodontic work. The EZ-Splint's narrow shape makes it favorable for daytime use.
- 5. Intended Use: Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome :hat is caused by chronic jaw clenching of the mandibular arıd maxillary teeth.
- 6. Comparison to Predicate Devices: Please refer to the following chart.

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### Attachment 4 Revised 7/16/03

| FEA URE | EZ-SPLINT EZ-SPLINT PM | Dr. HAYS BITE GUARD | NTI TENSION SUPPRESION SYST. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interferer.ce. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth. | Same | Same and for the prophylatic treatment of migraine pain. |
| Des gn | Adjustible, pre-formed oral appliance. The bite pads may be moved to adjust to the patient to prevent contact of posterior teeth and to provide a resilent break in the teeth clenching cycle. | Full mouth appliance that is custom molded by the practioner for the patient. | Customized by the practioner for the patient, fitted over the two maxillary central incisors with a dome shaped protrusion which extends lingually to prevent posterior of canine tooth contact |
| Ma erials | Elvax strap, Polypropelene and Kraton bites pads | Lexan and Elvax | Polycarbonate |
| Me hod of Manufacture | Injection molded | Dental laboratory molded | Injection molded |
| Pri scription Device | Yes | Yes | Yes |
| Re isable | Yes, single patient | Same | Same |
| Me thod of de infection | Warm water, soap, and toothbrush | Same | Same |

# 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non clinical tests were not performed.

- 8. Discussion of Clinical Tests Performed:

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### Attachment 4 Revised 7/16/03

Clinical tests were not performed

# . Conclusions:

The E.Z-Splint and the EZ-Splint PM are safe and effective for their intended use.

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol that appears to be a stylized representation of a caduceus, a traditional symbol of medicine, with a staff and two snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 2003

Power Products, Incorporated-Splintek C/O Ms. Carolann Kotula Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K022809

Trade/Device Name: EZ-Splint & EZ Splint PM Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: July 30, 2003 Received: July 31, 2003

Dear Ms. Kotula:

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. Kotula

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 (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.

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/dsma/dsmamain.html

Sincerely vours.

Patricia Cucento for

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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Splintek-PPI EZ-Splint: EZ-Splint PM K022809

K022809

Attachment 3 Revised 7/16/03

1 Page -

510(k) Number (if known): K022809

Device Name: EZ-Splint; EZ-Splint PM

Indications For Use:

- Protection against teeth grinding, bruxism and jaw clenching. .
- Short-term pain relief from muscle spasm due to occlusal interference. ●
- For the prevention of chronic tension and temporal mandibular joint (TMJ) . • syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------------------|---------|
| | |
| <i>Susan Runne</i> | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K022809 |

Prescription Use (Per 21 CFR 801.109)

-

OR

Over-The-Counter Use (Optional Format 1-2-96)