EKL · Point, Silver, Endodontic
Dental · 21 CFR 872.3840 · Class 1
Overview
| Product Code | EKL |
|---|---|
| Device Name | Point, Silver, Endodontic |
| Regulation | 21 CFR 872.3840 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal of a tooth.
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992582 | PACIFIC IMPLANT TITANIUM ENDODONTIC POINT | Pacific Implant, Inc. | Oct 21, 1999 | SESE |
| K961089 | PULPDENT ENDOPREP II | Pulpdent Corp. | Apr 23, 1996 | SESE |
| K822568 | EAR PROBES | Kelleher Corp. | Sep 14, 1982 | SESE |
Top Applicants
- Kelleher Corp. — 1 clearance
- Pacific Implant, Inc. — 1 clearance
- Pulpdent Corp. — 1 clearance
