Temporary

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 260-265-565

by Bicon, LLC

Identity

Trade Name: Temporary EUDAMED
Temporary Abutment FDA UDI
Generic Name: Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name: Dental Abutment EUDAMED
6.5 x 6.5mm Temporary Abutment - 2.5mm Post FDA UDI
Model / Reference: 260-265-565 EUDAMEDFDA UDI
Description: 6.5 x 6.5mm Temporary Abutment - 2.5mm Post FDA UDI

Identifiers

Catalog Number: 260-265-565 FDA UDI
Primary DI / UDI-DI: 00813110027351 EUDAMEDFDA UDI
Basic UDI-DI: B-00813110027351 EUDAMED
081311002TAbut5L 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 — 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-00813110027351	Class IIb	Active
EUDAMED	European Union	CE/MDD	B-00813110027351	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (3)

EUDAMED c5ed1bc3-2f90-4f74-8ec2-1f794fdd624a 61 fields · synced Jul 10, 2026
EUDAMED 534aeb6b-2c79-4cb6-a7f1-83e398b3091c 61 fields · synced May 19, 2026
FDA UDI 3d734938-23ee-408d-a4de-3cd6b7de1907 36 fields · synced May 30, 2026