510(k) · Cleared
ClearedCeradrill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebr. Brasseler GmbH & Co. KG · EJL Bur, Dental
Cleared on Jun 29, 2007 as substantially equivalent to K990846 (Nobel Biocare Uas, Inc., 1999) after a 45-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 29, 2007
- Review
- 45 days
- Class
- Class I
- Product code
- EJL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990846 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990846 Amorphous Diamond Coated DrillNobel Biocare Uas, Inc. · 1999 · Recalled
- This deviceK071352 CeradrillGebr. Brasseler GmbH & Co. KG · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990846 | Amorphous Diamond Coated Drill | Nobel Biocare Uas, Inc. | 1999 | 15 |
| 0 (this device) | K071352 | Ceradrill | Gebr. Brasseler GmbH & Co. KG | 2007 | — |
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 EJL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K990846 | Amorphous Diamond Coated DrillSummary page 2…marketed device to which your firm is claiming equivalence Company: Nobel Biocare USA, Inc. Device: Amorphous Diamond Coated Drill 510(k) No.: K990846 Description of the device: CeraDrills within the new "CeraLine" is intended for use in implantology. These are made of high eff… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
How does its category compare?
All EJL devicesEJL Bur, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EJL
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · EJL
Too few EJL 510(k)s in any year since 2007 to give a median.
Recalls per year · EJL
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EJL
54in 2025
MAUDE reports naming product code EJL, 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 | 1 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 32 |
| 2009 | 0 | — | 1 | 53 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 15 |
| 2019 | 0 | — | 1 | 17 |
| 2020 | 0 | — | 5 | 7 |
| 2021 | 0 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 1 | 25 |
| 2025 | 0 | — | 0 | 54 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement.
The drills are used with a handpiece.
CeraDrill is a ceramic drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece. The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.
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/K071352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071352: Ceradrill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071352
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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