510(k) · Cleared
ClearedSurgical Drills
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct Sybron Manufacturing, LLC · DZI Drill, Bone, Powered
Cleared on Jun 30, 2020 as substantially equivalent to K082532 (Straumann USA, 2008) after a 148-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Jun 30, 2020
- Review
- 148 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894844 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 1 generation backK082532 Straumann Guided InstrumentsStraumann USA · 2008
- This deviceK200265 Surgical DrillsImplant Direct Sybron Manufacturing, LLC · 2020
- Descendant · cites it directly · 0 of its ownK231087 Guided Surgery KitImplant Direct Sybron Manufacturing, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −1 | K082532 | Straumann Guided Instruments | Straumann USA | 2008 | — |
| 0 (this device) | K200265 | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | 2020 | — |
| +1 | K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082532 | Straumann Guided InstrumentsSummary page 4…Bone cutting instrument and accessories (21 CFR 872.4120) Regulatory Class: II Product Code: DZI III.PREDICATE DEVICE Predicate (primary) Straumann Guided Instruments (K082532) Predicate (reference) Swiss Plant Dental System (Surgical Drills) (K081396) IV. DEVICE DESCRIPTION The proposed Surgical Dril… | 2008 |
| † | K081396 | Swissplant Dental Implant System | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231087 | Guided Surgery Kit | 2023 | 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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231087 (Implant Direct Sybron Manufacturing, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082532.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200265: Surgical Drills.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200265
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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