LIGHT CURE DENTAL DAM

• K Number: K021524
• Device Name: LIGHT CURE DENTAL DAM
• Manufacturer: PRIME DENTAL MANUFACTURING, INC.
• Date Cleared: 2002-07-19 ( 70 days)
• Product Code: EIE
• Regulation Number: 872.6300
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Prime-Dent Light Cure Soft Dental Dam is for soft tissue isolation and moisture prevention/barrier.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "Prime-Dent Light Cure Soft Dental Dam." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is a regulatory approval, not a technical performance report.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on presenting experimental data regarding the device's performance against defined acceptance criteria.

Regulation Number and Section

§ 872.6300 Rubber dam and accessories.

(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.