510(k) · Cleared
ClearedSurgical Contra-Angle Handpieces, Models 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM and Surgical Straight Handpieces Mod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · DZA Drill, Dental, Intraoral
Cleared on Jun 25, 1999 after a 189-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 25, 1999
- Review
- 189 days
- Class
- Class I
- Product code
- DZA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK984508 Surgical Contra-Angle Handpieces, Models 975 AE,979 E/KM, 985 AE…W&H Dentalwerk Buermoos GmbH · 1999
- Descendant · cites it directly · 0 of its ownK022505 Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060…Nouvag AG · 2003
Most influential descendants
Showing 1 of 1 · See all- K022505Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063…Nouvag AG · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984508 | Surgical Contra-Angle Handpieces, Models 975 AE,979 E/KM, 985 AE, 986 AE, 988… | W&H Dentalwerk Buermoos GmbH | 1999 | — |
| +1 | K022505 | Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061… | Nouvag AG | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZA? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K022505 | Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063… | 2003 | 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?
- Of its descendants, K022505 (Nouvag AG, 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DZA devicesDZA Drill, Dental, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZA
FDA has decided no DZA device since 2007.
Median 510(k) review, days · DZA
Too few DZA 510(k)s in any year since 2007 to give a median.
Recalls per year · DZA
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZA
2in 2025
MAUDE reports naming product code DZA, 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 | 0 | — | 0 | 13 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 1 | 57 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications are very widespread in the field of oral surgery ranging from
A.
Implant placement, including
1. preparation of the osteotomy site
2. bone recontouring, osteoplasty
. Bone grafting
1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
2. harvesting autogen living bone
3. sinus elevation & grafting of alveolar sockets
. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
. Periodontal surgeries
1. bone recontouring & alveoplasty around living teeth
2. removal of exostosis
. Endodontic treatment
Intracanal preparations using rotating NiTi-files.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984508: Surgical Contra-Angle Handpieces, Models 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM and Surgical Straight Handpieces Mod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984508
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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