EBL · Pin, Retentive And Splinting, And Accessory Instruments
Dental · 21 CFR 872.3740 · Class 1
Overview
| Product Code | EBL |
|---|---|
| Device Name | Pin, Retentive And Splinting, And Accessory Instruments |
| Regulation | 21 CFR 872.3740 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A retentive and splinting pin is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be placed permanently in a tooth to provide retention and stabilization for a restoration, such as a crown, or to join two or more teeth together.
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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K002693 | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | Cbs Intl. B.V. | Nov 9, 2000 | SESE |
| K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | Dentauraum, Inc. | Jul 19, 1995 | SESE |
| K924376 | ROOT CANAL POST | The Thera Group | Nov 22, 1993 | SESE |
| K895283 | PROSTHETIC RESTORATION DEVICE | Swiss Precision Mfg. Corp. | Feb 14, 1990 | SESE |
| K895758 | PLASTIC TOOTH REINFORCEMENT KIT | Nanzee Dental Products | Dec 20, 1989 | SESE |
| K883074 | ELGILOY | Dale T. Dupuis | Aug 9, 1988 | SESE |
| K863831 | VIVADENT FILPIN | Vivadent (Usa), Inc. | Oct 14, 1986 | SESE |
| K844457 | SECURIPIN | Hughes Int'L, Inc. | Dec 27, 1984 | SESE |
| K830773 | MARKLEY THREADED WIRE | Almore Intl., Inc. | Apr 28, 1983 | SESE |
| K822412 | REINFORCING PIN | Filhol | Aug 30, 1982 | SESE |
| K760723 | SAFE-T-PINS RETENTIVE PIN SYSTEM | Parkell, Inc. | Oct 21, 1976 | SESE |
Top Applicants
- Vivadent (Usa), Inc. — 1 clearance
- The Thera Group — 1 clearance
- Swiss Precision Mfg. Corp. — 1 clearance
- Parkell, Inc. — 1 clearance
- Nanzee Dental Products — 1 clearance
