Barrier Sleeves

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K191448 ↗

FDA Product Code

PEM

FDA applicant

Ivoclar Vivadent, AG

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What are the Barrier Sleeves designed to protect in a dental setting and how do they ensure safety for both patients and operators?

  The Barrier Sleeves are specifically designed to protect dental instruments and equipment during procedures by creating a sterile barrier. They prevent contamination from oral fluids or pathogens, ensuring patient safety by isolating high-touch surfaces. For operators, this reduces the risk of exposure to infectious materials, maintaining a clean workspace throughout the procedure.

• Are the Barrier Sleeves reusable or intended for single-use, and how is sterility maintained?

  The Barrier Sleeves are explicitly designed for single-use only in dental settings. Sterility is maintained through their disposable nature—each sleeve is intended to be used once and discarded, eliminating the need for cleaning or reprocessing. This design ensures consistent protection and compliance with infection control standards.

• What sizes and shapes are available for the Barrier Sleeves, and how do they accommodate different dental instruments?

  The Barrier Sleeves come in various shapes and sizes to fit a range of dental instruments and equipment. While exact dimensions aren’t specified here, the product is categorized under Dental Barriers and Sleeves with multiple FDA registration numbers (e.g., 3015491448, 3038718579), indicating a broad compatibility with common dental tools. This versatility allows clinicians to select the appropriate sleeve for their specific procedures.

• How should the Barrier Sleeves be stored, and are there any special handling instructions?

  Since the Barrier Sleeves are disposable and designed for single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer recommends keeping them in their original packaging until use to preserve sterility and integrity. No special handling beyond standard sterile supply protocols is indicated.

• What regulatory pathway was followed for FDA clearance, and how does this affect their use in clinical settings?

  The Barrier Sleeves received FDA 510(k) clearance (K191448) under the Traditional 510(k) Review pathway, determined to be substantially equivalent to predicate devices. This clearance falls under 21 CFR 878.4370 (Surgical Drape and Drape Accessories) and was reviewed by the Dental Devices Panel (DE). Clinically, this means the product meets FDA standards for safety and effectiveness as a disposable barrier, allowing its use in dental settings without additional restrictions.