Skip to content

Promimic Dental Implant, 3.75 Mm, Length 8.5 Mm (03-1001 +3 more) - 03-1001

by Promimic AB

510(k) K101225

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101225 Date25 Jan 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
03-1001
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Promimic Dental Implant is a device intended for surgical placement into the bone of upper and lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. It is available in two models: one with a diameter of 3.75 mm and length of 8.5 mm (Model 03-1001), and another with a diameter of 3.75 mm and length of 10 mm (Model 03-1).

The device is manufactured by Promimic AB and has received FDA 510(k) clearance with decision code SESE and K number K101225. It is classified under product code DZE and was reviewed by the Dental advisory committee. The device is supplied as a sterile, single-use implant and should be stored according to the manufacturer's instructions.

Other devices from Promimic AB

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Promimic Dental Implant?

    The Promimic Dental Implant is designed for surgical placement into the bone of upper and lower jaw arches to serve as permanent anchorage for prosthetic devices and restore chewing function.

  • What models and sizes are available for the Promimic Dental Implant?

    The Promimic Dental Implant is available in two models: Model 03-1001 with a diameter of 3.75mm and length of 8.5mm, and Model 03-1 with a diameter of 3.75mm and length of 10mm.

  • Is the Promimic Dental Implant single-use or reusable?

    The Promimic Dental Implant is supplied as a sterile, single-use device and should not be reused. It should be stored according to the manufacturer's instructions until use.

  • What regulatory clearance has the Promimic Dental Implant received?

    The Promimic Dental Implant has received FDA 510(k) clearance with decision code SESE and K number K101225. It is classified under product code DZE and was reviewed by the Dental advisory committee.