# K101225: Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1

- Pathway: 510(k) (Traditional)
- Applicant: Promimic AB
- Decided: Jan 25, 2011 after 267 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K925765 (1993). 69 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073161: Replus Dental Implants (HA), Implant Direct, LLC (2008) Summary page 1.
- K062432: Nanotite Dental Implants, Implant Innovations, Inc. (2007) Summary page 1.
- K925765: Branemark System Standard 3.75MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- K991053: Astra Tech Implants - Dental System: New Fixtures (Micromacro), Astra Tech, Inc. (1999) Summary page 1.

## Most influential descendants
- K170392: S.I.N. Implant System (2017), 16 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own
- K200992: S.I.N. Dental Implant System (2020), 7 descendants of its own
- K211921: S.I.N. Dental Implant System (2021), 5 descendants of its own
- K222231: S.I.N. Dental Implant System (2022), 4 descendants of its own

## Indications for use
The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic Dental Implants are only to be used with straight abutments.

Source page: https://510kreport.com/device/K101225
Methodology: https://510kreport.com/methodology