Last synced on 2 December 2022 at 11:04 pm

Oral Wound Dressing

Page Type
Product Code
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Physical State
A viscous liquid or gel
Technical Method
Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound
Target Area
Oral mucosal tissue
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 OLR is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.

Oral Wound Dressing

Page Type
Product Code
Definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Physical State
A viscous liquid or gel
Technical Method
Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound
Target Area
Oral mucosal tissue
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 OLR is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.