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Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL

by Institut Straumann SA 2 variants

Ref 021.4512

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

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 Number0763003170115QL Basic UDI-DI 07630031706966UDI-DIDate25 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630031706966 UDI-DI Date24 Sep 2015ListedStatusListed 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

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2535-2016 FDA Class II initiated 14 Jul 2016
    • Terminated Z-2534-2016 FDA Class II initiated 14 Jul 2016

    Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

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  • Withdrawn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® Dental Implant System Roxolid® SLA Impl.
Generic Name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
021.4512, SLA Roxolid BL
Primary DI / UDI-DI
07630031706966
Basic UDI-DI
0763003170115QL
510(k) Number
FDA Product Code
DZE
EMDN Code
P01020101 Dental implants
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 12 Millimeter
Outer Diameter — 4.1 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
021.4512
GUDID
SLA Roxolid BL
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K150938)

Show all (11)

Other devices from Institut Straumann SA

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Properties

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

Other properties (18)

  • 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
  • Manufacturing Date: No