510(k) · Cleared
ClearedModification to Basic Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Basic Dental Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 28, 2001 as substantially equivalent to K960868 (Danlin Products, Inc., 1996) after a 21-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Nov 28, 2001
- Review
- 21 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960868 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960868 B.a.S.I.C. Dental Implant SystemDanlin Products, Inc. · 1996
- This deviceK013682 Modification to Basic Dental Implant SystemBasic Dental Implant Systems, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK072595 Omni-TightBasic Dental Implant Systems, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK082749 Omni-TightBasic Dental Implant Systems, Inc. · 2008
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 |
|---|---|---|---|---|---|
| −1 | K960868 | B.a.S.I.C. Dental Implant System | Danlin Products, Inc. | 1996 | — |
| 0 (this device) | K013682 | Modification to Basic Dental Implant System | Basic Dental Implant Systems, Inc. | 2001 | — |
| +1 | K072595 | Omni-Tight | Basic Dental Implant Systems, Inc. | 2008 | — |
| +2 | K082749 | Omni-Tight | Basic Dental Implant Systems, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K960868 | B.a.S.I.C. Dental Implant SystemSummary page 1…lacklock, Vice-President 505.881.1376 — Phone 505.884.1923 — Fax October 30, 2001 BASIC Dental Implant System Implant Dental implant DZE BASIC Dental Implant System K960868 The BASIC Dental Implant is an endosseous dental implant. The Implant for dental purposes, used to replace missing dental organ… | 1996 |
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 |
|---|---|---|---|
| K072595 | Omni-Tight | 2008 | 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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Implant for dental purposes, used to replace missing dental organs (teeth). The Implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the Implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).
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/K013682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013682: Modification to Basic Dental 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/K013682
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026