SICAT OPTIMOTION

K143655 · Sicat GmbH & Co. KG · MQC · Oct 2, 2015 · DE

Device Facts

• Record ID: K143655
• Device Name: SICAT OPTIMOTION
• Applicant: Sicat GmbH & Co. KG
• Product Code: MQC · DE
• Decision Date: Oct 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Protection of teeth and restorations from injury due to bruxism. Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension. Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.

Device Story

SICAT OPTIMOTION is a dental appliance designed for management of bruxism and Temporal Mandibular Disorder (TMD). Device functions as an occlusal splint to protect teeth and restorations from mechanical wear and to reduce muscle tension. Used in clinical settings by dental professionals; patient wears appliance to provide temporary relief from TMD symptoms, including associated headaches and orofacial pain. Device acts as a physical barrier and therapeutic aid to alleviate symptoms through stabilization of the jaw.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Occlusal splint device; custom-fitted dental appliance; non-implantable; intended for temporary intraoral use.

Indications for Use

Indicated for patients requiring protection of teeth/restorations from bruxism-related injury, and for temporary relief/treatment of Temporal Mandibular Disorder (TMD), bruxism, and associated headaches/pains.

Submission Summary (Full Text)

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

October 2, 2015

SICAT GmbH & Co. KG Dr. Manfred Breuer Head of Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, 53177 DE GERMANY

Re: K143655 Trade/Device Name: SICAT OPTIMOTION Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MOC Dated: August 15, 2015 Received: August 24, 2015

Dear Dr. Breuer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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 devicerelated 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K143655 510(k) Number (if known):

Device Name:

SICAT OPTIMOTION_

Indications for Use:

- Protection of teeth and restorations from injury due to bruxism.

- Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension.

- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k)________________________________________________________________________________________________________________________________________________________________________