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SEVEN IMPLANTS - Seven Implants

by Mis - Implant Technologies, Ltd.

510(k) K103089

SEVEN IMPLANTS - Seven Implants is a Class II device made by Mis - Implant Technologies, Ltd., cleared under FDA 510(k) K103089 on 15 Sep 2011, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103089 Date15 Sep 2011ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DZE
Models / Variants
Seven Implants
FDA applicant
Mis - Implant Technologies , Ltd.
Device class
Class II
Regulation
21 CFR Part 872.3640
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Devices cleared under K103089

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K103089
UDI-DISize and differences
MIS MF7-D06420
MIS Implants Technologies Ltd.
MF7-D06420 / MF7-D0642007290113997660 —On the market
MIS MF7-D06500
MIS Implants Technologies Ltd.
MF7-D06500 / MF7-D0650007290113997677 —On the market

Similar devices

Other devices filed under FDA product code DZE (Implant, Endosseous, Root-Form).

Other devices from MIS Implants Technologies Ltd.

See all devices from MIS Implants Technologies Ltd. →