510(k) · Cleared
ClearedImplantmed Plus II & Piezomed Plus II Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · DZI Drill, Bone, Powered
Cleared on Jun 18, 2026 as substantially equivalent to K161957 (W&H Dentalwerk Burmoos GmbH, 2016) and 1 other predicate after a 204-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jun 18, 2026
- Review
- 204 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002469 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- 2 generations backK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- 1 generation backK161957 W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016
- This deviceK253776 Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| −2 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| −1 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016 | — |
| 0 (this device) | K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 K253655 Angled Screwdriver MED (M-SD090)score 11.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K161957 | W&H Implantmed SI-1015 incl. AccessoriesSummary page 5…nt and accessories Drill, Bone, Powered 872.4120 DZI, ELC, EBW 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K161957 W&H Implantmed SI-1015 incl. Accessories EBW K133488 Piezomed DZI, ELC K243280 Piezomed Pro ERL, DZI, HY Device Description Summ… | 2016 |
| * | K133488 | PiezomedSummary page 5…ZI, ELC, EBW 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K161957 W&H Implantmed SI-1015 incl. Accessories EBW K133488 Piezomed DZI, ELC K243280 Piezomed Pro ERL, DZI, HY Device Description Summary 21 CFR 807.92(a)(4) new Implantmed Plus Il devi… | 2014 |
| † | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro… | 2025 |
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K161957.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Implantmed Plus II: Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (MF) for treatment of dental hard tissue. Piezomed Plus Module II: Piezoelectric ultrasonic device, consisting of handpieces and associated instruments, intended for: bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures…
Read the full statement (137 words)
Implantmed Plus II:
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 compatible coupling system, for
use in dental surgery, implantology and maxillofacial surgery (MF) for treatment of dental hard tissue.
Piezomed Plus Module II:
Piezoelectric ultrasonic device, consisting of handpieces and associated instruments, intended for:
bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology,
periodontal surgery, surgical orthodontic, and surgical endodontic procedures.
Scaling applications are including:
- Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits,
- Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket
irrigation and cleaning,
- Endodontic: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha-condensation and retrograde
preparation,
- Restorative and prosthetics: Cavity preparation, removal of prostheses, finishing of crown preparations.
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/K253776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253776: Implantmed Plus II & Piezomed Plus II Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253776
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026