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OT Equator SET OT EQUATOR ASTRA ø 3 + Smartbox h.4

by Rhein 83 SRL

Ref 131AS34

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Overview

Dental implant suprastructure, a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture) made of various materials such as titanium (Ti), plastic, gold alloy. This preformed device includes one or more structural component(s) like abutment screws or bar overlays.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805804571ADTK5 Basic UDI-DI 08059224161969UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224161969 UDI-DI Date30 Jun 2023ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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
OT EQUATOR ASTRA ø 3 h.4 c/Smart Box EUDAMED
OT Equator GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Attacchi Diretti in Titanio
Model / Ref / Catalog
131AS34, SET OT EQUATOR ASTRA ø 3 + Smartbox h.4
Primary DI / UDI-DI
08059224161969
Basic UDI-DI
805804571ADTK5
FDA Product Code
NHA
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
131AS34
GUDID
SET OT EQUATOR ASTRA ø 3 + Smartbox h.4
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Dental implant suprastructure, permanent, preformed

Other devices from Rhein 83 SRL

See all devices from Rhein 83 SRL →

Properties

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

Other properties (19)

  • 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
  • Expiration Date: No