EBE · Coating, Denture Hydrophilic, Resin
Dental · 21 CFR 872.3300 · Class 2
Overview
| Product Code | EBE |
|---|---|
| Device Name | Coating, Denture Hydrophilic, Resin |
| Regulation | 21 CFR 872.3300 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
A hydrophilic resin coating for dentures is a device that consists of a water-retaining polymer that is intended to be applied to the base of a denture before the denture is inserted into the patient's mouth to improve denture retention and comfort.
Classification Rationale
Class II (special 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.
Special Controls
*Classification.* Class II (special 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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832500 | CS-11 | Chema-Scutum, Inc. | Oct 27, 1983 | SESE |
| K830491 | JOHNSON & JOHNSON OPAQUE COLOR MODIFI | Johnson & Johnson Professionals, Inc. | Mar 17, 1983 | SESE |
| K790339 | CONCEPT II | Richardson Merrel, Inc. | Jul 17, 1979 | SESE |
Top Applicants
- Richardson Merrel, Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
- Chema-Scutum, Inc. — 1 clearance
