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Dental Abutment Design Software For Dental Laboratory

Page Type
Product Code
Definition
The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
Physical State
Device is composed of software contained in a standard desktop computer, stand-alone computer unit, or online software, an intra- or extra-oral scanner, and a CAM unit.
Technical Method
The device utilizes a digital image/impression of the patient's oral environment for the purpose of designing and creating a dental abutment. The device uses a validated CAM unit to create a physical version of the patient specific component of the dental abutment (i.e. abutment collar and abutment post). The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
Target Area
oral environment
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]

Dental Abutment Design Software For Dental Laboratory

Page Type
Product Code
Definition
The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
Physical State
Device is composed of software contained in a standard desktop computer, stand-alone computer unit, or online software, an intra- or extra-oral scanner, and a CAM unit.
Technical Method
The device utilizes a digital image/impression of the patient's oral environment for the purpose of designing and creating a dental abutment. The device uses a validated CAM unit to create a physical version of the patient specific component of the dental abutment (i.e. abutment collar and abutment post). The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
Target Area
oral environment
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]