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Temporary Abutment, non Sterile

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 048.501

by Institut Straumann AG

Identity

Trade Name
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
Temporary Abutment, non Sterile EUDAMED
NNC Post for temporary restoration, crown, H 10.3mm, TAN FDA UDI
Model / Reference
048.501 EUDAMED
Temporary Abutments FDA UDI
Description
NNC Post for temporary restoration, crown, H 10.3mm, TAN FDA UDI

Identifiers

Catalog Number
048.501 FDA UDI
Primary DI / UDI-DI
07630031724793 EUDAMEDFDA UDI
Basic UDI-DI
0763003170102QB EUDAMED
510(k) Number
K111357 FDA UDI
FDA Product Code
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3640 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

Temporary Abutment, non Sterile 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 4358dca2-fa6f-4973-8221-8f57f447df8e 61 fields · synced Jul 20, 2026
  • FDA UDI 53037f86-96af-4cf8-8ffd-bcde3a5ea9b0 37 fields · synced May 30, 2026