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Dio Biotite-H Implant Systems Sasa 4804

by DIO Corporation

Ref SASA 4804

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

Not checked

No FDA submission to match recalls against

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 Number880004921003A8 Basic UDI-DI 08800049274071UDI-DIDate25 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800049274071 UDI-DI Date21 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.

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  • Withdrawn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
SM Solid Abutment Analog EUDAMED
Dio Biotite-H Implant Systems GUDID
Generic Name
Screw endosteal dental implant, two-piece
Device Name
Dental Implant System Components and Accessories
Model / Ref / Catalog
SASA 4804
Primary DI / UDI-DI
08800049274071 EUDAMED
08806195916438 GUDID
Basic UDI-DI
880004921003A8
FDA Product Code
NHA
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08800049274071
GUDID
08806195916438
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes
ImplantableEUDAMED
No
GUDID
Yes

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Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • 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