510(k) · Cleared
ClearedBti Sterile Dental Drills Kit, Bti Abutments and Caps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.T.I. Biotechnology Institute, Sl. · EJL Bur, Dental
Cleared on Aug 3, 2006 as substantially equivalent to K022258 (B.T.I. Biotechnology Institute, Sl., 2003) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 3, 2006
- Review
- 77 days
- Class
- Class I
- Product code
- EJL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K935544 (1995). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
- 3 generations backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
- 2 generations backK022258 B.T.I. Biotechnology Institute, S.L. Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2003
- 1 generation backK053355 Bti Interna Dental Implant SystemB.T.I. Biotechnology Institute, Sl. · 2006
- This deviceK061383 Bti Sterile Dental Drills Kit, Bti Abutments and CapsB.T.I. Biotechnology Institute, Sl. · 2006
- Descendant · cites it directly · 1 of its ownK211952 BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · 2 generations on · 0 of its ownK232750 BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | 1995 | — |
| −3 | K013570 | Osseotite Dental Implants | Implant Innovations, Inc. | 2001 | — |
| −2 | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2003 | — |
| −1 | K053355 | Bti Interna Dental Implant System | B.T.I. Biotechnology Institute, Sl. | 2006 | — |
| 0 (this device) | K061383 | Bti Sterile Dental Drills Kit, Bti Abutments and Caps | B.T.I. Biotechnology Institute, Sl. | 2006 | — |
| +1 | K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +2 | K232750 | BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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? (2)
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 |
|---|---|---|---|
| * | K022258 | B.T.I. Biotechnology Institute, S.L. Dental Implant SystemSummary page 1…modified BTI Dental Implant System is claimed to be substantially equivalent in material, design, and function to BTI Dental Implant System cleared by FDA under 510 (k) K022258 on Sep 11, 2003 and 510 (k) 053355 on Mar 14, 2006. Page I of 2… | 2003 |
| * | K053355 | Bti Interna Dental Implant SystemSummary page 1…is claimed to be substantially equivalent in material, design, and function to BTI Dental Implant System cleared by FDA under 510 (k) K022258 on Sep 11, 2003 and 510 (k) 053355 on Mar 14, 2006. Page I of 2… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | 2022 | 1 |
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 11 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K211952 (B.T.I. Biotechnology Institute, Sl., 2022) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K022258.
How does its category compare?
All EJL devicesEJL Bur, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants.
Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061383: Bti Sterile Dental Drills Kit, Bti Abutments and Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061383
Report an extraction error
Are you the manufacturer?
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