Last synced on 1 March 2024 at 11:05 pm

Oral Wound Dressing W/Drug And/Or Biologic

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 OLS 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 W/Drug And/Or Biologic

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 OLS is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.