EKN · Point, Paper, Endodontic
Dental · 21 CFR 872.3830 · Class 1
Overview
| Product Code | EKN |
|---|---|
| Device Name | Point, Paper, Endodontic |
| Regulation | 21 CFR 872.3830 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry, or apply medication to, 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K843017 | ABSORBENT ENDODONTIC POINT | United Dental Mfg., Inc. | Jan 9, 1985 | SESE |
| K821625 | ENDODONTIC PAPERPOINTS | Roeko | Jun 14, 1982 | SESE |
| K812886 | ENDODONTIC PAPER POINTS | United Dental Mfg., Inc. | Nov 16, 1981 | SESE |
| K800827 | PREMIER ABSORBENT POINTS | Premier Dental Products Co. | Apr 29, 1980 | SESE |
| K781605 | R&R ABSORBENT POINTS | Ransom and Randolph | Oct 10, 1978 | SESE |
| K761203 | ABSORBENT POINTS | Johnson & Johnson Professionals, Inc. | Dec 13, 1976 | SESE |
| K760983 | ENDODONTIC INSTRUMENTS | Adp Intl., Inc. | Nov 15, 1976 | SESE |
Top Applicants
- United Dental Mfg., Inc. — 2 clearances
- Adp Intl., Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
- Premier Dental Products Co. — 1 clearance
- Ransom and Randolph — 1 clearance
