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Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA Temporary Abutments

by Institut Straumann SA

Ref 064.4390

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763003170073QV Basic UDI-DI 07630031759276UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630031759276 UDI-DI Date10 Jun 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
PMMA Temp Abutment
Model / Ref / Catalog
064.4390, Temporary Abutments
Description
WB Temporary Abutment, Ø 5.5mm, GH 1.5mmm, VITA CAD-Temp/TAN
Primary DI / UDI-DI
07630031759276
Basic UDI-DI
0763003170073QV
510(k) Number
FDA Product Code
NHA
EMDN Code
P01020101 Dental implants
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Height — 1.5 Millimeter
Outer Diameter — 5.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
064.4390
GUDID
Temporary Abutments
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No