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Abutment Screws

by JJGC Indústria e Comércio de Materiais Dentários S.A 18 variants

Ref 010.1247Model Abutment

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800108VL Basic UDI-DI 07899878030300UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878030300 UDI-DI Date10 Aug 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

6 recalls · 4 ongoing · FDA

    • Ongoing Z-3173-2026 FDA Class II initiated 12 Aug 2026 on shared 510(k) K163194

    There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

    • Ongoing Z-2929-2026 FDA Class II initiated 13 Jul 2026

    There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

  • 2 recalls, same reason

    • Ongoing Z-1863-2025 FDA Class II initiated 1 May 2025 on shared 510(k) K163194
    • Ongoing Z-1862-2025 FDA Class II initiated 1 May 2025 on shared 510(k) K163194

    It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

    • Terminated Z-0203-2022 FDA Class II initiated 11 Oct 2021 on shared 510(k) K163194

    3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.

    • Terminated Z-0455-2019 FDA Class II initiated 2 Oct 2018 on shared 510(k) K163194

    Laser engraved label does not match with the item in the package

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
Neodent
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Abutment Screws
Model / Ref / Catalog
Abutment, 010.1247
Primary DI / UDI-DI
07899878030300
Basic UDI-DI
987800108VL
FDA Product Code
NHA
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Outer Diameter — 4.1 Millimeter

Truth per registry

2 sources · 2 fields differ

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

Manufacturer details

EUDAMED SRN
BR-MF-000014512
Authorised representative
Etkon GmbH DE-AR-000009335

Other devices from JJGC Indústria e Comércio de Materiais Dentários S/A.

See all devices from JJGC Indústria e Comércio de Materiais Dentários S/A. →

Properties

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

Other properties (17)

  • 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