Last synced on 30 September 2022 at 11:05 pm

Mouthguard, Over-The-Counter

Page Type
Product Code
Definition
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Physical State
It is a material similar to a hard methylmethacrylate or a softer thermoplastic resin.
Technical Method
The dental mouthguard is a removable appliance that is fitted to the teeth by taking an immpression of the teeth or using a thermoplastic resin
Target Area
Oral Cavity
Review Panel
Dental
Submission Type
510(K)
Device Classification
U
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 OBR is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.

Mouthguard, Over-The-Counter

Page Type
Product Code
Definition
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Physical State
It is a material similar to a hard methylmethacrylate or a softer thermoplastic resin.
Technical Method
The dental mouthguard is a removable appliance that is fitted to the teeth by taking an immpression of the teeth or using a thermoplastic resin
Target Area
Oral Cavity
Review Panel
Dental
Submission Type
510(K)
Device Classification
U
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 OBR is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.