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Abutment, Implant, Dental, Endosseous

Page Type
Product Code
Definition
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3630
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3630 Endosseous dental implant abutment

§ 872.3630 Endosseous dental implant abutment.

(a) 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.

(b) 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.)

[69 FR 26304, May 12, 2004]

Abutment, Implant, Dental, Endosseous

Page Type
Product Code
Definition
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3630
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3630 Endosseous dental implant abutment

§ 872.3630 Endosseous dental implant abutment.

(a) 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.

(b) 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.)

[69 FR 26304, May 12, 2004]