510(k) · Cleared
Recalled · Class II · 2019Amorphous Diamond Coated Drill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Uas, Inc. · DZI Drill, Bone, Powered
Cleared on Jun 10, 1999 after an 87-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 15 times.
- Decided
- Jun 10, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- DZI
- Recalls
- 15
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK990846 Amorphous Diamond Coated DrillNobel Biocare Uas, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK071352 CeradrillGebr. Brasseler GmbH & Co. KG · 2007
Most influential descendants
Showing 1 of 1 · See all- K071352CeradrillGebr. Brasseler GmbH & Co. KG · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990846 | Amorphous Diamond Coated Drill | Nobel Biocare Uas, Inc. | 1999 | — |
| +1 | K071352 | Ceradrill | Gebr. Brasseler GmbH & Co. KG | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | — | Nobel Biocare USA, Inc. Steri-Oss System Surgical Drill Named without a submission number |
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 |
|---|---|---|---|
| K071352 | Ceradrill | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2019 | Class II | Z-1304-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1305-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1323-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1307-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1313-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1310-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1312-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1314-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1315-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1303-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1311-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1308-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1309-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Mar 14, 2019 | Class II | Z-1306-2020 | Packaging process control | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. |
| Jul 20, 2016 | Class II | Z-2375-2016 | Labeling design | Incorrect drill protocol in the Instructions for Use (IFU) |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071352 (Gebr. Brasseler GmbH & Co. KG, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use for this device is to cut into the maxilla or mandible to create an
osteotomy for endosseous dental implant placement. The amorphous diamond
coated drill design is intended to minimize corrosion and to increase longevity of
the tool.
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/K990846 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990846: Amorphous Diamond Coated Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990846
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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