510(k) · Cleared
ClearedBonding Base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZE Implant, Endosseous, Root-Form
Cleared on Dec 2, 1997 as substantially equivalent to K943720 (The Straumann Co., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1990. 67 later devices descend from it.
- Decided
- Dec 2, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894844 (1990). 2 ancestors in all. 67 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- This deviceK973353 Bonding BaseStraumann USA · 1997
- Descendant · cites it directly · 66 of its ownK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- Descendant · 2 generations on · 63 of its ownK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- Descendant · 2 generations on · 54 of its ownK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- Descendant · 2 generations on · 26 of its ownK042965 Tomas PinDentaurum, Inc. · 2005
- Descendant · 3 generations on · 19 of its ownK060126 Absoanchor MicroimplantDentos, Inc. · 2006
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K982509Ortho Implant and AccessoriesStraumann USA · 1998 · cites it directly66descendants
- K031936Osteomed Orthodontic Screw SystemOsteomed LP · 2004 · 2 generations on63descendants
- K033767Dual Top Anchor System ScrewsJeil Medical Corporation · 2004 · 2 generations on54descendants
- K042965Tomas PinDentaurum, Inc. · 2005 · 2 generations on26descendants
- K060126Absoanchor MicroimplantDentos, Inc. · 2006 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| 0 (this device) | K973353 | Bonding Base | Straumann USA | 1997 | — |
| +1 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| +2 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| +2 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| +2 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| +3 | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 9 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K943720 | Iti Transversal Screwing SystemSummary page 2…ame: Accessory to a dental implant (21 CFR 872.3640) Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Titanium Transverse Screw Coping (K943720) IT! Octa Gold Coping (K894844) 3M Unitek orthodontic bands Description of the Device The orthodontic bonding base is screwed on… | 1995 |
| * | K894844 | Bonefit Implant System Accessories & InstrumentsSummary page 2…ant (21 CFR 872.3640) Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Titanium Transverse Screw Coping (K943720) IT! Octa Gold Coping (K894844) 3M Unitek orthodontic bands Description of the Device The orthodontic bonding base is screwed onto the ITI Octa system. The bon… | 1990 |
| * | — | 3M Unitek orthodontic bands Named without a submission number | |
| * | — | ITI Transverse Screw Gold Coping Named without a submission number |
What descends from it? (67)
See all 671 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982509 | Ortho Implant and Accessories | 1998 | 66 |
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 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 bonding base is indicated for use with a standard 1Tl implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973353: Bonding Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973353
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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