21 CFR 872.3765 — Sealant, Pit And Fissure, And Conditioner
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3765
Identification
A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 130 | 3rd Party |
