Last synced on 23 September 2022 at 11:05 pm

Denture, Cosmetic Only

Page Type
Product Code
Definition
Intended to improve an individual's appearance only. Not intended to assist in chewing food.
Physical State
denture rebasing resin, methylmethacrylate
Technical Method
Functions independently
Target Area
oral cavity
Review Panel
Dental
Submission Type
Enforcement Discretion
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 NXJ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Denture, Cosmetic Only

Page Type
Product Code
Definition
Intended to improve an individual's appearance only. Not intended to assist in chewing food.
Physical State
denture rebasing resin, methylmethacrylate
Technical Method
Functions independently
Target Area
oral cavity
Review Panel
Dental
Submission Type
Enforcement Discretion
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 NXJ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.