21 CFR 872.3600 — Denture Preformed (Partially Prefabricated Denture)
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3600
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EKO | Denture Preformed (Partially Prefabricated Denture) | 2 | 4 |
Special Controls
EKO — Denture Preformed (Partially Prefabricated Denture)
*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.”
eCFR
EKO — Denture Preformed (Partially Prefabricated Denture)
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.”
Ecfr Llm
