(420 days)
Not Found
No
The device description focuses on material composition and physical design, with no mention of AI/ML terms or data processing.
Yes.
The device is intended for short-term pain relief, prevention of chronic tension and TMJ syndrome, indicating a therapeutic purpose.
No
Explanation: The Intended Use section describes the device's purpose as protection against teeth grinding, bruxism, and jaw clenching, and providing pain relief. These are therapeutic and preventative functions, not diagnostic ones. There is no mention of identifying or diagnosing a medical condition.
No
The device description explicitly states it is constructed of physical materials (Elvax 4. strap, polypropylene, and Kraton® bite pads) and is a physical appliance worn by the patient.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states the device is a physical appliance (a splint or bite guard) designed to be worn in the mouth to protect against teeth grinding, bruxism, and jaw clenching, and to provide pain relief. It does not involve testing samples from the body.
- Intended Use: The intended use is focused on physical protection and pain relief related to oral and jaw issues, not on diagnosing a condition through laboratory analysis.
Therefore, based on the provided information, this device falls under the category of a physical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Protection against teeth grinding, bruxism and jaw clenching. .
- Short-term pain relief from muscle spasm due to occlusal interference. o
- 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.
Product codes
LQZ, MQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular and maxillary teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non clinical tests were not performed.
Clinical tests were not performed
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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: 816-531-1900
- Carolann Kotula Contact Person: Official Correspondent for PPI-Splintek mdi Consultants, Inc. 55 Northern Blvd. Suite 410 Great Neck, NY 11021 Phone: 516-482-9001 516-482-0186 Fax: Alternate Phone: 770-985-8203 Alternate Fax: 770-736-8219 Email: ckotula@bellsouth.net
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
1
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.
-
- 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.
-
- Comparison to Predicate Devices: Please refer to the following chart.
2
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.
-
- Discussion of Clinical Tests Performed:
3
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.
4
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.
5
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
6
Splintek-PPI EZ-Splint: EZ-Splint PM 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) | |
|---|---|
| Susan Runne | |
| (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)