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JDEvolution

by Jdentalcare Srl 7 variants

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

510(k) K143142

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08055510170813 UDI-DI Date13 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143142 Date6 Nov 2015DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 21 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dental implant system
Model / Ref / Catalog
Cap attachment housing and elastic retentive cap, EVBAHC
Primary DI / UDI-DI
08055510170813
510(k) Number
FDA product code
NHA
GMDN term
Dental implant system
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Jdentalcare Srl

See all devices from Jdentalcare Srl →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Serial number

Other properties (10)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No
  • Expiration date: No
  • Manufacturing date: No