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Nexplant I5113-SH

by Achimhai Medical Corporation

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 23 Oct 2026

Documents

510(k) K172630

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800024914022 UDI-DI Date1 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172630 Date3 Apr 2018DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nexplant
Generic name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
I5113-SH
Primary DI / UDI-DI
08800024914022
510(k) Number
FDA product code
DZE
GMDN term
Screw endosteal dental implant, two-piece
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Screw endosteal dental implant, two-piece

Cleared under the same submission (K172630)

Show all (12)

Other devices from Achimhai Medical Corporation

See all devices from Achimhai Medical Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No