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Hi-Tec Implants N-Il

by Hi-Tec Implants

Hi-Tec Implants N-Il is a Class II device made by Hi-Tec Implants, cleared under FDA 510(k) K941575 on 17 Nov 1994 and listed in FDA GUDID since 16 Dec 2024 (UDI-DI 07290110729271), active as of 22 Oct 2026.

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 22 Oct 2026

Documents

510(k) K941575

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290110729271 UDI-DI Date16 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK941575 Date17 Nov 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K941575 decided 17 Nov 1994 Active
  • FDA GUDID UDI-DI 07290110729271 listed 16 Dec 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K941575
  2. Listed FDA GUDID 07290110729271

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hi-Tec Implants
Generic name
Dental implant analog
Model / Ref / Catalog
N-IL
Primary DI / UDI-DI
07290110729271
510(k) Number
FDA product code
NHA
GMDN term
Dental implant analog
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental implant analog

Cleared under the same submission (K941575)

and 8 more cleared under K941575

Similar devices in this category

Other devices filed under Dental implant analog.

Other devices from Hi-Tec Implants

See all devices from Hi-Tec Implants →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)