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Ora-Aid

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref TF-ORA-IFUModel OB23510(k) K211851

by TBM Corporation

Identity

Trade Name
Ora-Aid EUDAMEDFDA UDI
Generic Name
General oral wound dressing, non-animal-derived FDA UDI
Device Name
Ora-Aid EUDAMED
Model / Reference
OB23 EUDAMEDFDA UDI
TF-ORA-IFU EUDAMED

Identifiers

Primary DI / UDI-DI
08800026800149 EUDAMEDFDA UDI
Basic UDI-DI
88000268AG9R EUDAMED
510(k) Number
K211851 FDA UDI
FDA Product Code
OLR FDA UDI
EMDN Code
Q010304 PERIODONTAL DRESSINGS EUDAMED
GMDN Term
General oral wound dressing, non-animal-derived FDA UDI

Classification

Device Class
Class I EUDAMED
U FDA UDI
Market of Registration
Greece EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ora-Aid by TBM Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
TBM Corporation
EUDAMED SRN
KR-MF-000008542
Authorised Representative
KTR Europe GmbH DE-AR-000005685

Sources (3)

  • EUDAMED 2096e894-64b4-4ad2-bbfb-571896306b2f 85 fields · synced Jun 18, 2026
  • FDA UDI 3f28930a-1e42-4b3b-988d-1273ffaff40e 35 fields · synced May 30, 2026
  • FDA 510(k) K211851 1 fields · synced May 18, 2026