510(k) · Cleared
ClearedSNUCONE Tissue Level Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Snucone Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 8, 2023 as substantially equivalent to K181137 (Neobiotech Co., Ltd., 2018) after a 265-day review. Its family tree reaches back 8 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 8, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894595 (1990). 18 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 4 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 3 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 2 generations backK090527 Sinus Quick IT SystemNeobiotech Co., Ltd. · 2009
- 1 generation backK181137 IT-III active SystemNeobiotech Co., Ltd. · 2018
- This deviceK222792 SNUCONE Tissue Level Implant SystemSnucone Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK242753 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK250280 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −4 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −3 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −2 | K090527 | Sinus Quick IT System | Neobiotech Co., Ltd. | 2009 | — |
| −1 | K181137 | IT-III active System | Neobiotech Co., Ltd. | 2018 | — |
| 0 (this device) | K222792 | SNUCONE Tissue Level Implant System | Snucone Co., Ltd. | 2023 | — |
| +1 | K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
| +2 | K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K181137 | IT-III active SystemSummary page 4…ropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. 06. Predicate and Reference Devices Primary Predicate - K181137, IT-III active System manufactured by NEOBIOTECH CO., LTD Reference Devices - K141159, K3Pro Konus Dental Implant System… | 2018 |
| † | K141159 | Konus Dental Implant System | 2015 |
| † | K121585 | TS Implant System | 2013 |
| † | K181138 | IS-III active System | 2018 |
| † | K200189 | Luna Dental Implant System- Healing Abutment | 2020 |
| † | K120043 | CSM Internal-R Implant System | 2012 |
| † | K201700 | BEGO Semados® RS/RSX Implant System | 2021 |
| † | K190637 | Fit & Brilliant Dental Implant System | 2020 |
| † | K210161 | AnyOne Onestage Implant System | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242753 | SD TL Implant System | 2025 | 1 |
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 33 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K242753 (Arum Dentistry Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
SNUCONE Tissue Level Implant System is indicated for use in paitially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or inte1mediate Abutment support for fixed bridge work. Snucone implant system is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222792: SNUCONE Tissue Level Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222792
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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