EKO · Denture Preformed (Partially Prefabricated Denture)
Dental · 21 CFR 872.3600 · Class 2
Overview
| Product Code | EKO |
|---|---|
| Device Name | Denture Preformed (Partially Prefabricated Denture) |
| Regulation | 21 CFR 872.3600 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
A partially fabricated denture kit is a device composed of connected preformed teeth that is intended for use in construction of a denture. A denture base is constructed using the patient's mouth as a mold, by partially polymerizing the resin denture base materials while the materials are in contact with the oral tissues. After the denture base is constructed, the connected preformed teeth are chemically bonded to the base.
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. The special controls for this device are FDA's:
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. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K903672 | DENE BRIDGE | Dirotian Pty. , Ltd. | Dec 5, 1990 | SESE |
| K892255 | DENTAL ROOT ELEVATOR | Zinnanti Surgical Instruments, Inc. | May 1, 1989 | SESE |
| K780722 | ADVANCED DENTURE SYSTEM | Advanced Marketing Research Co. | May 26, 1978 | SESE |
| K760768 | FLEXIDENT DENTURE | Flexodent Corp. | Oct 15, 1976 | SESE |
Top Applicants
- Advanced Marketing Research Co. — 1 clearance
- Dirotian Pty. , Ltd. — 1 clearance
- Flexodent Corp. — 1 clearance
- Zinnanti Surgical Instruments, Inc. — 1 clearance
