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Nuvo CD1829008

by JJGC Indústria e Comércio de Materiais Dentários S/A.

Part of a family of 41 devices: see the family page

Ref CD1829008Model Abutment

Nuvo CD1829008 is a device classified as Class IIa in the EU and Class II in the US made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 6 May 2026 (Basic UDI-DI 987800086W3), cleared under FDA 510(k) K193234 on 18 Jun 2020 and listed in FDA GUDID since 25 Oct 2024 (UDI-DI 07899878065678), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193234

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800086W3 Basic UDI-DI 07899878065678UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878065678 UDI-DI Date25 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193234 Date18 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 987800086W3 registered 6 May 2026 Active
  • FDA 510(k) K193234 decided 18 Jun 2020 Active
  • FDA GUDID UDI-DI 07899878065678 listed 25 Oct 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193234
  2. Listed FDA GUDID 07899878065678
  3. Registered EUDAMED 987800086W3

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Nuvo
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Permanent Abutments over Abutments
Model / Ref / Catalog
CD1829008, Abutment
Primary DI / UDI-DI
07899878065678
Basic UDI-DI
987800086W3
510(k) Number
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 registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional
Size
Outer Diameter — 4.8 Millimeter
Height — 5.0 Millimeter

Truth per registry

2 sources · 2 fields differ

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

Device class is stated on each registry's own scale: Class IIa 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

Cleared under the same submission (K193234)

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

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

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)