510(k) · Cleared
ClearedContour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bennett Jacoby, Dds, Ms, Inc. · DZI Drill, Bone, Powered
Cleared on Jun 9, 2020 as substantially equivalent to K113152 (Dmetec.Co., Ltd., 2012) and 2 other predicates after a 315-day review. Its family tree reaches back 9 generations to 1986. 1 of the 37 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 9, 2020
- Review
- 315 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K862807 (1986). 36 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations between
- 3 generations backK100410 Piezoelectric SystemSatelec · 2010
- 2 generations backK132848 Piezosurgery FlexMectron S.P.A. · 2013
- 1 generation backK153743 Piezosurgery PlusMectron S.P.A. · 2016
- This deviceK192033 Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip…Bennett Jacoby, Dds, Ms, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 7 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 5 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 4 generations backK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- 3 generations backK100410 Piezoelectric SystemSatelec · 2010
- 2 generations backK132848 Piezosurgery FlexMectron S.P.A. · 2013
- 1 generation backK153743 Piezosurgery PlusMectron S.P.A. · 2016
- This deviceK192033 Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip…Bennett Jacoby, Dds, Ms, Inc. · 2020
Class I recalls in this family
- K043310 Synthes (Usa) Electric Pen Drive System4 generations back · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −8 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −7 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −5 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −4 | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| −3 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| −2 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| −1 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| 0 (this device) | K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour… | Bennett Jacoby, Dds, Ms, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 1 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K113152 | Ultrasonic Surgery MachineSummary page 4…510(k) No. Sponsor Surgystar Predicate Device Dmetec Co. Ltd. DZI K113152 Diamond Coated Reference Device 1 Dentsply ELC K030111 Inserts… | 2012 |
| * | K030111 | Diamondcoat Ultrasonic InsertsSummary page 4…Predicate Device Dmetec Co. Ltd. DZI K113152 Diamond Coated Reference Device 1 Dentsply ELC K030111 Inserts International Piezosurgery Plus Reference Device 2 Mectorn S.p.a. J… | 2003 |
| * | K153743 | Piezosurgery PlusSummary page 4…K030111 Inserts International Piezosurgery Plus Reference Device 2 Mectorn S.p.a. JDX, DZI, ERL, K153743 HBE, HWE Pa… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K043310Synthes (Usa) Electric Pen Drive SystemSynthes (Usa) · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 36 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K113152.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses:
1. Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
2. Soft tissue debridement and removal, particularly in intrabony lesions.
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/K192033 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192033: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192033
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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