510(k) · Cleared
ClearedNobel Biocare Endosseous Implants (Maxillofacial Indication)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · FZE Prosthesis, Nose, Internal
Cleared on Jun 2, 2009 as substantially equivalent to K945154 (Nobelpharma USA, Inc., 1995) after an 85-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jun 2, 2009
- Review
- 85 days
- Class
- Class II
- Product code
- FZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945154 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945154 BA-CpasNobelpharma USA, Inc. · 1995
- This deviceK090630 Nobel Biocare Endosseous Implants (Maxillofacial Indication)Nobel Biocare AB · 2009
- Descendant · cites it directly · 1 of its ownK161548 Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK241253 Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945154 | BA-Cpas | Nobelpharma USA, Inc. | 1995 | — |
| 0 (this device) | K090630 | Nobel Biocare Endosseous Implants (Maxillofacial Indication) | Nobel Biocare AB | 2009 | — |
| +1 | K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016 | — |
| +2 | K241253 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 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 FZE? 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 FZE device
- #1 K241253 Medicon Epiplating Systemscore 9.1 · 3 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K945154 | BA-CpasSummary page 1…Trade or Proprietary or Model Name: Nobel Biocare Endosseous Implants (Maxillofacial Indication) Legally Marketed Devices: Nobel Biocare - BA-CPAS (K945154) Device Description: This submission extends the indication for the Nobel Biocare Endosseous Implants to use in maxillofacial… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161548 | Osseointegrated Fixtures | 2016 | 1 |
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?
How does its category compare?
All FZE devicesFZE Prosthesis, Nose, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FZE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FZE
Too few FZE 510(k)s in any year since 2007 to give a median.
Recalls per year · FZE
No recall names FZE since 2007.
Adverse event reports per year · FZE
13in 2025
MAUDE reports naming product code FZE, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 26 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090630: Nobel Biocare Endosseous Implants (Maxillofacial Indication).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090630
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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