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US/SS/GS System SPS100TH

by OSSTEM IMPLANT Co., Ltd.

Ref SPS100TH

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406CLASSIBUSANHY Basic UDI-DI 08809892366452UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809892366452 UDI-DI Date4 Nov 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
US Standard Plastic Cylinder EUDAMED
US/SS/GS System GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Impression Tool System
Model / Reference
SPS100TH
Primary DI / UDI-DI
08809892366452
Basic UDI-DI
88000406CLASSIBUSANHY
510(k) Number
FDA Product Code
NHA
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K073247)

Show all (12)

Other devices from OSSTEM IMPLANT Co., Ltd.

See all devices from OSSTEM IMPLANT Co., Ltd. →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • 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
  • Expiration Date: No