Periovance 7374-601

GUDID 10850058655007

Natural oral rinse for inflammation and pain relieve prior and post dental procedures

ORABIO, INC.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID10850058655007
NIH Device Record Keya0e8a38c-320b-4080-bb39-9cba246f08c5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeriovance
Version Model Number7374-601
Catalog Number7374-601
Company DUNS119105756
Company NameORABIO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com
Phone8447672246
Emailcustomersupport@orabio.com

Device Dimensions

Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter
Total Volume16 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850058655000 [Primary]
GS110850058655007 [Package]
Contains: 00850058655000
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-10
Device Publish Date2024-05-31

Devices Manufactured by ORABIO, INC.

00850058655055 - Periovance Dry Mouth Gel2025-04-17 40mL Dry Mouth Gel
00850058655109 - Periovance Dry Mouth Gel2025-04-17 Dry Mouth Gel - Mini
10850058655007 - Periovance2024-06-10Natural oral rinse for inflammation and pain relieve prior and post dental procedures
10850058655007 - Periovance2024-06-10 Natural oral rinse for inflammation and pain relieve prior and post dental procedures

Trademark Results [Periovance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERIOVANCE
PERIOVANCE
98194634 not registered Live/Pending
Periovance Inc.
2023-09-24

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.