21 CFR 872.3140 — Applicator, Resin

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3140

Identification

A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Product Codes