FDA.reportPublic FDA data

Ora-Aid

Primary DI
08800026800156
Brand
Ora-Aid
Company
TBM Corporation
Model
OB53
Published
2022-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLROral Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLROral Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211851000Ora-AidTbm Corporation2022-01-11OLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800026800156PrimaryGS10
08800026800408Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800026800156088000268001568800026800156
08800026800408088000268004088800026800408

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, non-animal-derivedA compound intended to be used as a protective cover for the general oral mucosa to treat mouth wounds and sores such as ulcers and lesions caused by trauma, surgery, radiotherapy/chemotherapy or dental prostheses/orthodontic braces; it may in addition be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis, or to prevent mouth wounds/lesions. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) [e.g., polysaccharides, hyaluronic acid, dimethicone] and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home and clinical setting. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82629712845admin@tbmkorea.com

Regulatory Flags#

DUNS number
688452907
Device count
20
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026800149Ora-AidOB232022-06-21
08800026800408Ora-AidOB532022-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04714691213958VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2026-03-30
04714691213934VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-11-04
04714691213903HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213910HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213897HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-22
04714691213859HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-06-12
04714691213705Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213712Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
04714691213682Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213699Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
00860013569907MuGardSoleva Pharma LLCOLR2025-02-28
04714691213552HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213569HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213576HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850443Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850450Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213521HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213538HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213545HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213606Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213590Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850467Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213132Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213170Omniplug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213477HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213484HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691850283HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691850290HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-26
04714691213460HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-07-22
10686864060779MedicomAMD Medicom IncOLR2024-05-08