(148 days)
Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
This document is a 510(k) premarket notification for a medical device called "Dental Barrier and Sleeves." It outlines the device's characteristics and compares them to a legally marketed predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: This submission is for a Class II medical device, "Dental Barrier and Sleeves," which are physical barriers (polyethylene covers) for dental instruments and equipment. The document does not describe an AI/Software as a Medical Device (SaMD) and therefore doesn't contain information related to AI model performance, expert consensus on image interpretation, or multi-reader multi-case studies. The performance criteria and studies described are for the physical properties and biocompatibility of the barrier sleeves themselves.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on demonstrating equivalence in physical properties and biocompatibility with the predicate device.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Method) | Reported Device Performance and Outcome |
|---|---|---|
| Intended Use | Same intended use as predicate device | Same: "disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only." |
| Classification | Class II (21 CFR 878.4370) | Same: Class II (21 CFR 878.4370) |
| Product Code | PEM | Same: PEM |
| Material | Polyethylene film (same composition as predicate or justified) | Same: Polyethylene film (LLDPE 80%, LDPE 20%) |
| Specifications & Tolerances | Film Thickness: 0.02-0.06mm, Tolerance: |
§ 878.4370 Surgical drape and drape accessories.
(a)
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.(b)
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.