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Sm Internal/External Implant Systems Amn 35428

by DIO Corporation

Ref AMN 35428

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880004925011B3 Basic UDI-DI 08800049405277UDI-DIDate25 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800049405277 UDI-DI Date12 Jan 2016ListedStatusListed GUDID: not 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 7 Nov 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  • Withdrawn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
FTN Cemented Abutment EUDAMED
Sm Internal/External Implant Systems GUDID
Generic Name
Screw endosteal dental implant, two-piece
Device Name
FTN Implant Prosthetic Components
Model / Ref / Catalog
AMN 35428
Primary DI / UDI-DI
08800049405277 EUDAMED
08806195927731 GUDID
Basic UDI-DI
880004925011B3
510(k) Number
FDA Product Code
DZE
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08800049405277
GUDID
08806195927731
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Related devices

Cleared under the same submission (K070569)

Show all (12)

Other devices from DIO Corporation

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Properties

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

Other properties (16)

  • 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