510(k) · Cleared
ClearedOdontosurge 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Periogiene · EKZ Unit, Electrosurgical, And Accessories, Dental
Cleared on Jun 11, 1998 as substantially equivalent to K962445 (Arthrocare Corp., 1996) after a 56-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 11, 1998
- Review
- 56 days
- Class
- Class II
- Product code
- EKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943450 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 2 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 1 generation backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- This deviceK981390 Odontosurge 2Periogiene · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −2 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −1 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| 0 (this device) | K981390 | Odontosurge 2 | Periogiene | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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 EKZ? 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 EKZ device
- #1 K213477 Root ZX3score 5.3 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K962445 | Arthrocare Dental Electrosurgery SystemSummary page 1…mmary was prepared April 16, 1998 Name of the device ODONTOSURGE 2 Identification of predicate device ArthroCare Dental Electrosurgery System ArthroCare Corporation K962445 Description of the device The ODONTOSURGE 2 is a high frequency electrosurgery unit that is comprised of the following three pr… | 1996 |
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 3 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K962445.
How does its category compare?
All EKZ devicesEKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EKZ
Too few EKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · EKZ
No recall names EKZ since 2007.
Adverse event reports per year · EKZ
6in 2018
MAUDE reports naming product code EKZ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ODONTOSURGE 2 is intended for use in removing soft tissue and controlling bleeding in
the oral cavity during surgical procedures in all phases of dentistry, including prosthodontics,
periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative
dentistry.
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/K981390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981390: Odontosurge 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981390
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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