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S-Plant SPFS7011W

by Idis Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809984970420 UDI-DI Date7 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
S-Plant
Generic Name
Screw endosteal dental implant, two-piece
Model / Reference
SPFS7011W
Primary DI / UDI-DI
08809984970420
510(k) Number
FDA Product Code
DZE
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 7.0 Millimeter
Length — 11.5 Millimeter

Related devices

Cleared under the same submission (K231429)

Other devices from Idis Co., Ltd.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No