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JDEvolution

by Jdentalcare Srl 19 variants

Part of a family of 21 devices: see the family page

Ref EVHB55Model JDEvolution Cover screws and Healing Abutments

JDEvolution (EVHB55) is a device classified as Class IIb in the EU and Class II in the US made by Jdentalcare Srl, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 8055510170002VR), cleared under FDA 510(k) K143142 on 6 Nov 2015 and listed in FDA GUDID since 31 May 2018 (UDI-DI 08055510170400), active as of 15 Oct 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 15 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143142

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 15 Oct 2026.

Regulatory status

as of registry sync 15 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8055510170002VR Basic UDI-DI 08055510170400UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08055510170400 UDI-DI Date31 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143142 Date6 Nov 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8055510170002VR registered 26 May 2026 Active
  • FDA 510(k) K143142 decided 6 Nov 2015 Active
  • FDA GUDID UDI-DI 08055510170400 listed 31 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143142
  2. Listed FDA GUDID 08055510170400
  3. Registered EUDAMED 8055510170002VR

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  • Withdrawn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
Healing Abutment Bicomponent Ø 5.0 H 5.0 JDEvolution EUDAMED
JDEvolution GUDID
Generic name
Dental implant system
Model / Ref / Catalog
JDEvolution Cover screws and Healing Abutments, EVHB55, Healing Abutment bi-component D 5.0 H 5.0 JDEvolution
Primary DI / UDI-DI
08055510170400
Basic UDI-DI
8055510170002VR
510(k) Number
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
JDEvolution Cover screws and Healing Abutments
EVHB55
GUDID
Healing Abutment bi-component D 5.0 H 5.0 JDEvolution
Device classEUDAMED
Class IIb
GUDID
Class II

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 system

Cleared under the same submission (K143142)

and 8 more cleared under K143142

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Jdentalcare Srl

See all devices from Jdentalcare Srl →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Serial number
Other properties (20, all answered No)