SPHERO BLOCK NORMO S/BLOCK NORMO CERTAIN 3I ø 4, 1 h.2 TiN

by Rhein 83 SRL

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD821002IIC42R0 UDI-DI	Date2 Jul 2018Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Sphero Block Normo
Generic Name: Dental implant suprastructure, permanent, preformed
Model / Reference: S/BLOCK NORMO CERTAIN 3I ø 4, 1 h.2 TiN

Primary DI / UDI-DI: D821002IIC42R0
FDA Product Code: DZE
GMDN Term: Dental implant suprastructure, permanent, preformed

Device Class: Class II
Regulation Number: 872.3640
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization
MRI Safety: MR Unsafe

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No