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Screws

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 048.356Ref 025.2908Ref 025.4906Ref 048.350V4Ref 025.2900

by Institut Straumann AG

Identity

Trade Name
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS FDA UDI
BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS FDA UDI
CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS FDA UDI
RN SYNOCTA UCLA GOLD ABUT. FOR STRAUMANN DENTAL IMPLANT FDA UDI
STRAUMANN DENTAL IMPLANT SYSTEM FDA UDI
Generic Name
Dental prosthesis/implant abutment screw FDA UDI
Device Name
Screws EUDAMED
RC Basal Screw, for Ceramic Abutment only, TAN FDA UDI
SCS Occlusal screw, length 4.4 mm, titanium FDA UDI
NC Basal Screw, for Cementable Abutment only, TAN FDA UDI
synOcta® Basal screw L 6,7 mm, TAN FDA UDI
NC Basal Screw, TAN FDA UDI
Model / Reference
048.356 EUDAMED
025.2908 EUDAMED
025.4906 EUDAMED
048.350V4 EUDAMED
025.2900 EUDAMED
Screws FDA UDI
Description
RC Basal Screw, for Ceramic Abutment only, TAN FDA UDI
SCS Occlusal screw, length 4.4 mm, titanium FDA UDI
NC Basal Screw, for Cementable Abutment only, TAN FDA UDI
synOcta® Basal screw L 6,7 mm, TAN FDA UDI
NC Basal Screw, TAN FDA UDI

Identifiers

Catalog Number
025.4906 FDA UDI
048.350V4 FDA UDI
025.2908 FDA UDI
048.356 FDA UDI
025.2900 FDA UDI
Primary DI / UDI-DI
07630031724243 EUDAMEDFDA UDI
07630031712608 EUDAMEDFDA UDI
07630031724199 EUDAMEDFDA UDI
07630031711823 EUDAMEDFDA UDI
07630031711731 EUDAMEDFDA UDI
Basic UDI-DI
0763003170080QS EUDAMED
Unit of Use DI
07630031757944 EUDAMED
510(k) Number
K072151 FDA UDI
K894844 FDA UDI
K080286 FDA UDI
K041295 FDA UDI
K062129 FDA UDI
FDA Product Code
NHA FDA UDI
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
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

Screws 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 (10)

  • EUDAMED 79f29c88-9cb9-461e-904e-87ac3ca51795 61 fields · synced Aug 1, 2026
  • FDA UDI e6e0e72a-146b-459b-9c8d-8d02f9d50061 36 fields · synced May 30, 2026
  • FDA UDI c03ef9bb-2e6b-4e66-8e62-f5b54347e589 36 fields · synced May 30, 2026
  • FDA UDI cbef336a-4c81-4362-878f-8570d878cfd8 36 fields · synced May 30, 2026
  • FDA UDI 68b5b4c5-9123-42a7-a3b2-2dccb894a1c5 37 fields · synced May 30, 2026
  • FDA UDI e90e0499-e208-4b93-a8b4-19995fd55c40 36 fields · synced May 30, 2026
  • EUDAMED a61688be-fcc2-49e8-9a9f-369f99731450 61 fields · synced Jul 9, 2026
  • EUDAMED 847fc647-2716-430e-b065-4b56a3b48acf 61 fields · synced Jul 24, 2026
  • EUDAMED fb38e27f-5f11-4772-b210-e862df0b538a 61 fields · synced Jul 25, 2026
  • EUDAMED b32277d0-f82e-4562-b284-db0c4f4b6cb3 61 fields · synced Jul 31, 2026