510(k) · Cleared
ClearedSterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterngold/Implamed · DZE Implant, Endosseous, Root-Form
Cleared on May 11, 1998 after a 13-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1,066 later devices descend from it.
- Decided
- May 11, 1998
- Review
- 13 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
1,066 later devices descend from it, 4 citing it directly.
- This deviceK981516 Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed…Sterngold/Implamed · 1998
- Descendant · cites it directly · 1,043 of its ownK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- Descendant · 2 generations on · 942 of its ownK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- Descendant · 2 generations on · 735 of its ownK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- Descendant · 3 generations on · 689 of its ownK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- Descendant · 4 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
Showing 5 of 1,066 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,066 · See all- K984104Iti Dental Implant SystemStraumann USA · 1999 · cites it directly1,043descendants
- K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Nobel Biocare Uas, Inc. · 2000 · 2 generations on942descendants
- K992937Dental ImplantNobel Biocare Uas, Inc. · 2000 · 2 generations on735descendants
- K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · 3 generations on689descendants
- K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 4 generations on622descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981516 | Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw… | Sterngold/Implamed | 1998 | — |
| +1 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| +2 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| +2 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| +3 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| +4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 17 | 0 |
| 2006 | 26 | 0 |
| 2007 | 29 | 0 |
| 2008 | 38 | 0 |
| 2009 | 32 | 0 |
| 2010 | 28 | 0 |
| 2011 | 39 | 0 |
| 2012 | 40 | 0 |
| 2013 | 54 | 0 |
| 2014 | 50 | 0 |
| 2015 | 48 | 0 |
| 2016 | 53 | 0 |
| 2017 | 49 | 0 |
| 2018 | 49 | 0 |
| 2019 | 41 | 0 |
| 2020 | 74 | 0 |
| 2021 | 55 | 0 |
| 2022 | 60 | 0 |
| 2023 | 74 | 0 |
| 2024 | 78 | 0 |
| 2025 | 66 | 0 |
| 2026 | 33 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1,066)
See all 1,0664 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984104 | Iti Dental Implant System | 1999 | 1,043 |
| K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | 2004 | 441 |
| K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | 2004 | 327 |
| K031322 | Intra-Lock Hydroxyapatite Coated Implants | 2003 | 0 |
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, K984104 (Straumann USA, 1999) has gone furthest, with 1,043 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 | — |
What is it indicated for?
The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentuous and partially dentate patients in the maxillae and mandible. Implant retsined restoration may consist of single crowns or bridges as well as complete or partial déntures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981516: Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981516
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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