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Final Abutment: BL Abutment

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 010.6109

by Institut Straumann AG

Identity

Trade Name
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Final Abutment: BL Abutment EUDAMED
RC Cementable Abutment, Ø 5mm, GH 3mm, AH 4mm, Ti FDA UDI
Model / Reference
010.6109 EUDAMED
Final Abutments FDA UDI
Description
RC Cementable Abutment, Ø 5mm, GH 3mm, AH 4mm, Ti FDA UDI

Identifiers

Catalog Number
010.6109 FDA UDI
Primary DI / UDI-DI
07630031739155 EUDAMEDFDA UDI
Basic UDI-DI
0763003170072QT EUDAMED
510(k) Number
K072071 FDA UDI
FDA Product Code
NHA FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 3 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI
Height — 4 Millimeter FDA UDI

Final Abutment: BL Abutment by Institut Straumann AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Institut Straumann AG
EUDAMED SRN
CH-MF-000009933
Authorised Representative
Etkon GmbH DE-AR-000009335

Sources (2)

  • EUDAMED 9233dac3-d7fb-4cdf-b7a2-7de3a6e9d933 61 fields · synced Jul 24, 2026
  • FDA UDI 57e0bf24-21ed-4709-ba45-e37b43154319 37 fields · synced May 30, 2026