SPHERO FLEX

RHEIN 83 SRL · Model SPHERO FLEX ANKYLOS C/X h.1 · UDI-DI 08059224087139

EGG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. Retentive caps, metal housing for the caps, directional rings and protective disc.

Recalls

Date	Firm	Reason
2008-01-10	Straumann Usa, Llc	Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diamete

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.