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JDEvolution Plus

by Jdentalcare Srl 140 variants

Part of a family of 74 devices: see the family page

Ref EVA37080:Model JDEvolution Plus Dental implants

JDEvolution Plus (EVA37080:) is a device classified as Class IIb in the EU and Class II in the US made by Jdentalcare Srl, registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 8055510170100VS), cleared under FDA 510(k) K233896 on 16 Aug 2024 and listed in FDA GUDID since 2 Sep 2024 (UDI-DI 08056591012047), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233896

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8055510170100VS Basic UDI-DI 08056591012047UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056591012047 UDI-DI Date2 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233896 Date16 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8055510170100VS registered 1 Jun 2026 Active
  • FDA 510(k) K233896 decided 16 Aug 2024 Active
  • FDA GUDID UDI-DI 08056591012047 listed 2 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K233896
  2. Listed FDA GUDID 08056591012047
  3. Registered EUDAMED 8055510170100VS

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  • Withdrawn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
JDEvolution Plus Anodized Collar Ø 3.7 L 8 EUDAMED
JDEvolution Plus GUDID
Generic name
Dental implant system
Model / Ref / Catalog
JDEvolution Plus Dental implants, EVA37080:, JDEvolution Plus Anodized Collar Ø 3.7 L 8
Primary DI / UDI-DI
08056591012047
Basic UDI-DI
8055510170100VS
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Dental implant system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
JDEvolution Plus Dental implants
EVA37080:
GUDID
JDEvolution Plus Anodized Collar Ø 3.7 L 8
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 (K233896)

and 8 more cleared under K233896

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Jdentalcare Srl

See all devices from Jdentalcare Srl →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)