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Self Thread/Logic Plus/Spark Lht-L

by Hi-Tec Implants

Self Thread/Logic Plus/Spark Lht-L 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 12 Jun 2017 (UDI-DI 07290110726270), 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 Number07290110726270 UDI-DI Date12 Jun 2017ListedStatusListed 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 07290110726270 listed 12 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K941575
  2. Listed FDA GUDID 07290110726270

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Self Thread/Logic Plus/Spark
Generic name
Dental implant/prosthesis surgical procedure kit
Model / Ref / Catalog
LHT-L
Primary DI / UDI-DI
07290110726270
510(k) Number
FDA product code
NHA
GMDN term
Dental implant/prosthesis surgical procedure kit
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NHA (Abutment, Implant, Dental, Endosseous).

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)