EJX · Anchor, Preformed
Dental · 21 CFR 872.3130 · Class 1
Overview
| Product Code | EJX |
|---|---|
| Device Name | Anchor, Preformed |
| Regulation | 21 CFR 872.3130 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K133088 | ZX-27 | M&M Dental Studio, Inc. | Jan 2, 2015 | SESE |
Top Applicants
- M&M Dental Studio, Inc. — 1 clearance
