Temporary

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 260-373-725

by Bicon, LLC

Identity

Trade Name: Temporary EUDAMED
Temporary Abutment FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: Dental Abutment EUDAMED
7.5 x 2.5mm Scannable Temporary Abutment - 3.0mm Post FDA UDI
Model / Reference: 260-373-725 EUDAMEDFDA UDI
Description: 7.5 x 2.5mm Scannable Temporary Abutment - 3.0mm Post FDA UDI

Identifiers

Catalog Number: 260-373-725 FDA UDI
Primary DI / UDI-DI: 00813110028914 EUDAMEDFDA UDI
Basic UDI-DI: B-00813110028914 EUDAMED
081311002TAbut5L EUDAMED
510(k) Number: K853788 FDA UDI
FDA Product Code: DZE FDA UDI
EMDN Code: P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Temporary by Bicon, Llc — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-00813110028914	Class IIb	Active
EUDAMED	European Union	CE/MDD	B-00813110028914	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

Manufacturer: Bicon, LLC
EUDAMED SRN: US-MF-000002782
Authorised Representative: Bicon Europe Ltd IE-AR-000002497

Sources (3)

EUDAMED d69848d4-603f-450a-8e96-bfdfdc4213d5 61 fields · synced Jul 15, 2026
EUDAMED 95652315-65a5-45fe-a79e-001fd05d77b4 61 fields · synced May 19, 2026
FDA UDI b58d3d78-32ba-4da8-8a51-24994521232e 36 fields · synced May 30, 2026