Identifiers
- 510(k) Number
- K132953 FDA 510(k)
- FDA Product Code
- PEM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
TIDISHEILD is a dental barrier and sleeve device. It is designed for use in general and plastic surgery settings to provide protective equipment for medical staff and patients.
The device is supplied as a single-use product and is not MRI compatible. It is stored at room temperature and has received FDA 510(k) clearance with the product code PEM.
Frequently asked questions
What is the TIDISHEILD device used for?
TIDISHEILD is a dental barrier and sleeve device designed for use in general and plastic surgery settings to provide protective equipment for medical staff and patients.
Is the TIDISHEILD device reusable or single-use?
The TIDISHEILD device is supplied as a single-use product and is not MRI compatible. It should be discarded after each use to maintain sterility and effectiveness.
What regulatory clearance has the TIDISHEILD device received?
TIDISHEILD has received FDA 510(k) clearance with the product code PEM. It is classified as a Class II device and is substantially equivalent to predicate devices in the dental barriers and sleeves category.
How should the TIDISHEILD device be stored?
The TIDISHEILD device should be stored at room temperature in its original packaging until ready for use to maintain its integrity and sterility.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medical Products for Staff & Patient Safety | TIDI Products, Protective Equipment for Nurses | Healthcare PPE | TIDI Products, TIDI Products - LinkedIn, TIDISHEILD 510 (k) K132953 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132953 | Class II | Active |
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Manufacturer
- Manufacturer
- Tidi Products, Llc
- FDA Applicant
- Tidi Products,Llc
Sources (1)
- FDA 510(k) K132953 24 fields · synced Sep 25, 2026