510(k) · Cleared
ClearedBranemark System 3.3MM Fixture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobelpharma USA, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 8, 1995 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Mar 8, 1995
- Review
- 167 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK944683 Branemark System 3.3MM FixtureNobelpharma USA, Inc. · 1995
- Descendant · cites it directly · 6 of its ownK021322 Endossous ImplantsIntra-Lock International · 2002
- Descendant · 2 generations on · 5 of its ownK103194 Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK112787 KeratorKj Meditech Co., Ltd. · 2012
- Descendant · 3 generations on · 1 of its ownK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
- Descendant · 2 generations on · 0 of its ownK241183 ISO AbutmentSeum Medi Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K021322Endossous ImplantsIntra-Lock International · 2002 · cites it directly6descendants
- K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011 · 2 generations on5descendants
- K112787KeratorKj Meditech Co., Ltd. · 2012 · cites it directly3descendants
- K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013 · 3 generations on1descendant
- K241183ISO AbutmentSeum Medi Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944683 | Branemark System 3.3MM Fixture | Nobelpharma USA, Inc. | 1995 | — |
| +1 | K021322 | Endossous Implants | Intra-Lock International | 2002 | — |
| +2 | K103194 | Intra-Lock Dental Implants with Blossom | Intra-Lock International, Inc. | 2011 | — |
| +1 | K112787 | Kerator | Kj Meditech Co., Ltd. | 2012 | — |
| +3 | K130140 | Intra-Lock OP Dental Implant | Intra-Lock International | 2013 | — |
| +2 | K241183 | ISO Abutment | Seum Medi Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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?
- Of its descendants, K021322 (Intra-Lock International, 2002) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K944683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944683: Branemark System 3.3MM Fixture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944683
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026