Skip to content

Highness Implant System HS-VII4511

by Highness Co., Ltd.

Ref HS-Ⅶ4511

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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/MDD EUDAMED NumberB-08800108303629 Basic UDI-DI 08800108303629UDI-DIDate24 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number08800108303629 UDI-DI Date10 Dec 2025ListedStatusListed 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  • Withdrawn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  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Highness Implant System
Generic Name
Screw endosteal dental implant, two-piece
Device Name
Dental Implant System
Model / Reference
HS-Ⅶ4511 EUDAMED
HS-VII4511 GUDID
Primary DI / UDI-DI
08800108303629
Basic UDI-DI
B-08800108303629
510(k) Number
FDA Product Code
DZE
EMDN Code
P01020101 Dental implants
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
HS-Ⅶ4511
GUDID
HS-VII4511
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K240383)

Show all (12)

Other devices from Highness Co., Ltd.

See all devices from Highness Co., Ltd. →

Properties

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

Other properties (15)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Serial Number: No