Last synced on 2 December 2022 at 11:04 pm

Crown And Bridge Material, Resin Based

Page Type
Product Code
Definition
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications.
Physical State
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications
Technical Method
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications
Target Area
Tooth
Review Panel
Dental
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PKJ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Crown And Bridge Material, Resin Based

Page Type
Product Code
Definition
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications.
Physical State
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications
Technical Method
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications
Target Area
Tooth
Review Panel
Dental
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PKJ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.