SPHERO BLOCK MICRO SET S.BLOCK M. BIOHORIZONS ø 5 h2

by Rhein 83 SRL

Ref 003BH52R

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

Certifier ICIM S.P.A.

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number805804571ADTK5 Basic UDI-DI 08059224064116UDI-DI	Date18 Mar 2026Registered	StatusActive
European Union	CE/MDR EUDAMED	Number0425-MDR-030107-02	Date21 Jan 2026Issued	StatusActive expires 2 Dec 2029
United States	GUDID listing GUDID	Number08059224064116 UDI-DI	Date3 Jul 2025Listed	StatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: S. BLOCK MICRO/BIO HORIZONS ø 5 h.2 TiN EUDAMED
Sphero Block Micro GUDID
Generic Name: Dental implant suprastructure, permanent, preformed
Device Name: Attacchi Diretti in Titanio
Model / Ref / Catalog: 003BH52R, SET S.BLOCK M. BIOHORIZONS ø 5 h2

Primary DI / UDI-DI: 08059224064116
Basic UDI-DI: 805804571ADTK5
FDA Product Code: DZE
EMDN Code: Q010299 Prosthetic dentistry devices - other
GMDN Term: Dental implant suprastructure, permanent, preformed

Device Class: Class IIb EUDAMED
Class II GUDID
Regulation Number: 872.3640
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

Field	EUDAMED	GUDID
Model / Reference	EUDAMED 003BH52R	GUDID SET S.BLOCK M. BIOHORIZONS ø 5 h2
Device Class	EUDAMED Class IIb	GUDID Class II

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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