FDA.reportPublic FDA data

Ora-Aid

Primary DI
08800026800408
Brand
Ora-Aid
Company
TBM Corporation
Model
OB53
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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-derived, non-sterileA non-sterile 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 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., gel, fluid, spray) for use in the home or a clinical setting. After application, this device cannot be reused.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688452907
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026800156Ora-AidOB532022-06-21
08800026800149Ora-AidOB232022-06-21

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