510(k) · Cleared
ClearedArthrocare Dental Electrosurgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · EKZ Unit, Electrosurgical, And Accessories, Dental
Cleared on Jul 30, 1996 as substantially equivalent to K943450 (Arthrocare Corp., 1995) and 3 other predicates after a 36-day review. Its family tree reaches back 2 generations to 1995. 1,325 later devices descend from it.
- Decided
- Jul 30, 1996
- Review
- 36 days
- Class
- Class II
- Product code
- EKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K943450 (1995). 4 ancestors in all. 1,325 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 1 generation backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- This deviceK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- Descendant · cites it directly · 1,322 of its ownK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- Descendant · cites it directly · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- Descendant · 2 generations on · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- Descendant · 3 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- Descendant · cites it directly · 1,029 of its ownK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
Showing 5 of 1,325 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,325 · See all- K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,322descendants
- K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · cites it directly1,219descendants
- K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · 2 generations on1,073descendants
- K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 3 generations on1,069descendants
- K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,029descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −1 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| 0 (this device) | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| +1 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| +1 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| +2 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| +3 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| +1 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 14 | 0 |
| 2003 | 24 | 0 |
| 2004 | 16 | 0 |
| 2005 | 20 | 0 |
| 2006 | 18 | 0 |
| 2007 | 21 | 0 |
| 2008 | 44 | 0 |
| 2009 | 31 | 0 |
| 2010 | 40 | 0 |
| 2011 | 28 | 0 |
| 2012 | 35 | 0 |
| 2013 | 47 | 0 |
| 2014 | 48 | 0 |
| 2015 | 56 | 0 |
| 2016 | 73 | 0 |
| 2017 | 69 | 0 |
| 2018 | 59 | 0 |
| 2019 | 49 | 0 |
| 2020 | 62 | 0 |
| 2021 | 68 | 0 |
| 2022 | 85 | 0 |
| 2023 | 81 | 0 |
| 2024 | 101 | 0 |
| 2025 | 136 | 0 |
| 2026 | 84 | 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? (4)
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 |
|---|---|---|---|
| * | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970Summary page 1…n Dental Electrosurgical Unit and Accessories name: (21 CFR 872.4920) B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System K943450 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-electrode K961069 Electrosurgery System Parkel… | 1995 |
| * | K955531 | Arthrocare Bipolar Loop Electrode SystemSummary page 1…CFR 872.4920) B. Predicate devices Device Premarket Notification ArthroCare Arthroscopic Electrosurgery System K943450 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-electrode K961069 Electrosurgery System Parkell 500SE Sensimatic Electrosurge K952039 C. Device descri… | 1996 |
| * | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery SystemSummary page 1…emarket Notification ArthroCare Arthroscopic Electrosurgery System K943450 ArthroCare Bipolar Loop Electrosurgery System K955531 ArthroCare Urologic Multi-electrode K961069 Electrosurgery System Parkell 500SE Sensimatic Electrosurge K952039 C. Device description The ArthroCare Dental Electrosurgery S… | 1996 |
| * | K950239 | Sensimatic 500SE Our OCR of the scanned summary read K952039, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Parkell 500SE Sensimatic Electrosurge”. | 1995 |
What descends from it? (1,325)
See all 1,3256 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 year and passes through 1 company; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K964849 (Arthrocare Corp., 1997) has gone furthest, with 1,322 descendants of its own.
- 10 other devices also cite its predicate K943450.
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 ArthroCare Dental Electrosurgery System is intended for use in dental and periodontal surgical procedures to remove soft tissue and to control bleeding in the oral cavity.
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/K962445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962445: Arthrocare Dental Electrosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962445
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