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Ot Equator Mini Extragrade+screw+seeger ø4

by Rhein 83 SRL

Part of a family of 277 devices: see the family page

Ref MM40SEG

Ot Equator Mini Extragrade+screw+seeger ø4 (MM40SEG) is a device classified as Class IIb in the EU and Class I in the US made by Rhein 83 SRL, registered in EUDAMED on 18 Mar 2026 (Basic UDI-DI 805804571CSPLL) with CE/MDR certificate 0425-MDR-030107-02 valid until 2 Dec 2029 and listed in FDA GUDID since 7 Jul 2025 (UDI-DI 08059224166117), active as of 24 Oct 2026.

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

CE MDR

Valid until

2 Dec 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805804571CSPLL Basic UDI-DI 08059224166117UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224166117 UDI-DI Date7 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805804571CSPLL registered 18 Mar 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08059224166117 listed 7 Jul 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030107-02 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    21 Jan 2026
    Expires
    2 Dec 2029

Timeline

4 dated events

  1. Listed FDA GUDID 08059224166117
  2. Certificate issued EUDAMED 0425-MDR-030107-02
  3. Registered EUDAMED 805804571CSPLL
  4. Certificate expires EUDAMED 0425-MDR-030107-02

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  • Withdrawn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
Mini T-Base Extragrade+vite+seeger ø4 EUDAMED
Ot Equator GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Componenti per Protesi Fissa
Model / Ref / Catalog
MM40SEG, MINI EXTRAGRADE+SCREW+SEEGER ø4
Primary DI / UDI-DI
08059224166117
Basic UDI-DI
805804571CSPLL
FDA product code
EJX
EMDN code
Q010299 Prosthetic dentistry devices - other
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
872.3130
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MM40SEG
GUDID
MINI EXTRAGRADE+SCREW+SEEGER ø4
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Rhein 83 SRL

See all devices from Rhein 83 SRL →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)