Sphero Block Micro

FDA UDI

Class II (US FDA UDI)

by Rhein 83 Srl

Identity

Trade Name: SPHERO BLOCK MICRO FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla. FDA UDI
Model / Reference: SPHERO B/MICRO BIO VENT ø 4.5 h.4 TiN FDA UDI
Description: Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla. FDA UDI

Identifiers

Primary DI / UDI-DI: D821003BV454R0 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

Yes

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Implantable

Yes

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

The SPHERO BLOCK MICRO is a titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. It provides permanent intermediate fixture level between the implant and final prosthesis/restoration, including one or more structural components such as abutments, bars, or rings, and can be made of various materials like titanium (Ti), plastic, or gold alloy. This device is screwed into an endosseous implant in the mandible or maxilla for optimal retention and stability.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Rhein 83 Srl

Sources (1)

FDA UDI 8d836512-4c55-4b78-8d34-ea7997059000 34 fields · synced Jul 17, 2026