TIDISHEILD

K132953 · Tidi Products,Llc · PEM · Feb 18, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132953
• Device Name: TIDISHEILD
• Applicant: Tidi Products,Llc
• Product Code: PEM · General, Plastic Surgery
• Decision Date: Feb 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The TIDIShield Curing Light Sleves are indicated for used as an accessory to dental instrument. These sleves are non-sterile and are intended for single patient use only.

Device Story

TIDIShield Curing Light Sleeves are disposable, non-sterile protective barriers designed for dental curing lights. The sleeves act as a physical cover to prevent cross-contamination between patients during dental procedures. They are custom-fitted for specific curing light models, including SmartLite Max, BluePhase, Elipar S10, and Demetron Ultra. The device is used by dental professionals in a clinical environment. By providing a barrier, the sleeve reduces the need for chemical disinfection of the curing light handpiece between patients, thereby protecting the equipment and supporting infection control protocols.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-sterile, single-use plastic sleeves custom-fitted to specific dental curing light models. The device functions as a physical barrier to prevent cross-contamination.

Indications for Use

Indicated for use as a protective accessory for dental curing lights. Intended for single-patient use in a dental clinical setting.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

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

February 18, 2014

TIDI Products, LLC Mr. Dion Brandt Quality Manager 570 Enterprise Drive Neenah, WI 54956

Re: K132953

Trade/Device Name: TIDIShield TM Curing Light Sleeve Regulation Number: 21 CFR 878.4370 Regulation Name: Dental Barriers and Sleeves Regulatory Class: Class II Product Code: PEM Dated: September 17, 2013 Received: January 15, 2014

Dear Mr. Brandt:

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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### Page 2 - Mr. Brandt

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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Erin I. Keith, M.S. Acting 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Slatement on last page.

## 510(k) Number (if known) K132953

#### Device Name TIDIShield Curing Light Sleeve

| Indications for Use (Describe) | | |
|--------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | | The TIDIShield Curing Light Sleves are indicated for used as an accessory to dental instrument. These sleves |
| | are non-sterile and are intended for single patient use only. | |
| Part Number | Model | Custom Fit For: |
| 21103 | TIDIShield Curing Light Sleeve | SmartLite Max/Dentsply Curing Light |
| 21102 | TIDIShield Curing Light Sleeve | BluePhase/Ivoclar Curing Light |
| 21101 | TIDIShield Curing Light Sleeve | Eliphar S10/3M Curing Light |
| 21100 | TIDIShield Curing Light Sleeve | Demil Iltra/Kerr Curing Light |

Type of Use (Select one or both, as applicable)

[] Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

11 ***** FOR FOR FOR FOR FOR LY 。 : ﺎﺭ. .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth F. Claverie -S 2014.02.14 23:59:46 -05"00

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