21 CFR 872.3630 — Abutment, Implant, Dental, Endosseous
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3630
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Classification Rationale
Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 702 | Implant |
| PNP | Dental Abutment Design Software For Dental Laboratory | 2 | 8 | SaMD, Implant |
Special Controls
NHA — Abutment, Implant, Dental, Endosseous
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
eCFR
NHA — Abutment, Implant, Dental, Endosseous
The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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PNP — Dental Abutment Design Software For Dental Laboratory
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
eCFR
