Temporary

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 260-250-520

by Bicon, LLC

Identity

Trade Name: Temporary EUDAMED
Healing Abutment FDA UDI
Generic Name: Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name: Dental Abutment EUDAMED
5.0 x 4.0mm Healing Abutment - 2.5mm Post FDA UDI
Model / Reference: 260-250-520 EUDAMEDFDA UDI
Description: 5.0 x 4.0mm Healing Abutment - 2.5mm Post FDA UDI

Identifiers

Catalog Number: 260-250-520 FDA UDI
Primary DI / UDI-DI: 00813110021939 EUDAMEDFDA UDI
Basic UDI-DI: 081311002PAbut48 EUDAMED
B-00813110021939 EUDAMED
510(k) Number: K092035 FDA UDI
FDA Product Code: NHA FDA UDI
EMDN Code: P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
GMDN Term: Dental implant suprastructure, temporary, preformed, single-use FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 872.3630 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 — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	081311002PAbut48	Class IIb	Active
EUDAMED	European Union	CE/MDR	081311002PAbut48	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 8bc904cf-6eb7-4a74-a80e-c4ebfad65974 61 fields · synced Jun 1, 2026
EUDAMED a159767d-21cb-4e25-ae42-bbe0a4607872 61 fields · synced May 19, 2026
FDA UDI 7bce0628-d15e-494c-8bc6-fe8160483e91 36 fields · synced May 30, 2026