510(k) · Cleared
ClearedPromimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promimic AB · DZE Implant, Endosseous, Root-Form
Cleared on Jan 25, 2011 as substantially equivalent to K073161 (Implant Direct, LLC, 2008) and 3 other predicates after a 267-day review. Its family tree reaches back 9 generations to 1993. 18 later devices descend from it.
- Decided
- Jan 25, 2011
- Review
- 267 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K925765 (1993). 69 ancestors in all, the oldest K781060 (1978). 18 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- This deviceK101225 Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001…Promimic AB · 2011
- Descendant · cites it directly · 16 of its ownK170392 S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
- Descendant · 2 generations on · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · 2 generations on · 7 of its ownK200992 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · 3 generations on · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
- Descendant · 2 generations on · 4 of its ownK222231 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · Recalled
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- This deviceK101225 Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001…Promimic AB · 2011
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017 · cites it directly16descendants
- K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 2 generations on8descendants
- K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 2 generations on7descendants
- K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 3 generations on5descendants
- K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| 0 (this device) | K101225 | Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental… | Promimic AB | 2011 | — |
| +1 | K170392 | S.I.N. Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2017 | — |
| +2 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +2 | K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +3 | K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021 | — |
| +2 | K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073161 | Replus Dental Implants (HA)Summary page 1…I per regulations 872.3640 Product Codes: DZE 2. Equivalent devices Promimic AB believes the Promimic Dental Implant is substantially equivalent to: K073 161 Implant Direct Inc Replus Dental Implants (HA) K(062432 Implant Innovation Inc NanoTite Dental Im… | 2008 |
| * | K062432 | Nanotite Dental ImplantsSummary page 1…s Promimic AB believes the Promimic Dental Implant is substantially equivalent to: K073 161 Implant Direct Inc Replus Dental Implants (HA) K(062432 Implant Innovation Inc NanoTite Dental Implants K925765 Nobeipharmia USA Inc Biinemark System… | 2007 |
| * | K925765 | Branemark System Standard 3.75MM FixtureSummary page 1…equivalent to: K073 161 Implant Direct Inc Replus Dental Implants (HA) K(062432 Implant Innovation Inc NanoTite Dental Implants K925765 Nobeipharmia USA Inc Biinemark System Standard 3.75 mm Fixture K99 1053 Astra Tech Inc… | 1993 |
| * | K991053 | Astra Tech Implants - Dental System: New Fixtures (Micromacro)Summary page 1…K(062432 Implant Innovation Inc NanoTite Dental Implants K925765 Nobeipharmia USA Inc Biinemark System Standard 3.75 mm Fixture K99 1053 Astra Tech Inc Astra Tech Implants- Dental system: New fixtures (micromacro) 3. Description of th… | 1999 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 10 of the 69 ancestors have a recall of any class.
- Of its descendants, K170392 (S.I.N. – Sistema DE Implante Nacional S.A., 2017) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K073161.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101225 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101225
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026