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Straight Abutments NM-A5517

by Noris Medical Ltd

Ref NM-A5517

Straight Abutments NM-A5517 is a device classified as Class IIb in the EU and Class II in the US made by Noris Medical Ltd, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI B-07290108816822) and listed in FDA GUDID since 20 Nov 2017 (UDI-DI 07290108816822), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290108816822 Basic UDI-DI 07290108816822UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108816822 UDI-DI Date20 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07290108816822 registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 07290108816822 listed 20 Nov 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290108816822
  2. Registered EUDAMED B-07290108816822

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Blank Abut Ti. EUDAMED
Straight Abutments GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Internal Hex Dental Abutments
Model / Ref / Catalog
NM-A5517
Primary DI / UDI-DI
07290108816822
Basic UDI-DI
B-07290108816822
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 07290108816822: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Noris Medical Ltd

See all devices from Noris Medical Ltd →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (16, all answered No)