510(k) · Cleared
ClearedStraumann Guided Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZI Drill, Bone, Powered
Cleared on Oct 21, 2008 as substantially equivalent to K894844 (Straumann Institute, Ltd., 1990) after a 49-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Oct 21, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894844 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- This deviceK082532 Straumann Guided InstrumentsStraumann USA · 2008
- Descendant · cites it directly · 1 of its ownK200265 Surgical DrillsImplant Direct Sybron Manufacturing, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK231087 Guided Surgery KitImplant Direct Sybron Manufacturing, LLC · 2023
- Descendant · cites it directly · 0 of its ownK090260 Modification to:Straumann Guided InstrumentsStraumann Manufacturing, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC · 2020 · cites it directly1descendant
- K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC · 2023 · 2 generations on0descendants
- K090260Modification to:Straumann Guided InstrumentsStraumann Manufacturing, Inc. · 2009 · cites it directly0descendants
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) | K082532 | Straumann Guided Instruments | Straumann USA | 2008 | — |
| +1 | K200265 | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | 2020 | — |
| +2 | K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | 2023 | — |
| +1 | K090260 | Modification to:Straumann Guided Instruments | Straumann Manufacturing, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 DZI? 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 DZI device
- #1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K894844 | Bonefit Implant System Accessories & InstrumentsSummary page 1…Number: §872.4120 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Bone Cutting Instruments, K894844 4. Description of the Device The Straumann P.004 Dental Implant System is an integrated system of end… | 1990 |
What descends from it? (3)
2 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?
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DZI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZI
300in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZI
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZI
39in 2025
MAUDE reports naming product code DZI, 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 | 2 | — | 0 | 53 |
| 2008 | 4 | 171 | 0 | 45 |
| 2009 | 5 | 220 | 1 | 22 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 4 | 191 | 0 | 25 |
| 2013 | 0 | — | 0 | 57 |
| 2014 | 1 | — | 0 | 50 |
| 2015 | 3 | 123 | 0 | 39 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 3 | 290 | 0 | 73 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 3 | 300 | 0 | 55 |
| 2021 | 0 | — | 0 | 84 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082532: Straumann Guided Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082532
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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