510(k) Report

510(k) · Cleared

Cleared

B.a.S.I.C. Dental Implant System

K960868510(k) TraditionalCleared Nov 14, 1996255-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Danlin Products, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Nov 14, 1996 after a 255-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Nov 14, 1996
Review
255 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2008: 2 descendants cleared1995200020052010201520202025
  1. This deviceK960868 B.a.S.I.C. Dental Implant SystemDanlin Products, Inc. · 1996
  2. Descendant · cites it directly · 2 of its ownK013682 Modification to Basic Dental Implant SystemBasic Dental Implant Systems, Inc. · 2001
  3. Descendant · 2 generations on · 1 of its ownK072595 Omni-TightBasic Dental Implant Systems, Inc. · 2008
  4. Descendant · 3 generations on · 0 of its ownK082749 Omni-TightBasic Dental Implant Systems, Inc. · 2008
  5. Descendant · cites it directly · 0 of its ownK022912 Post and Core - Thin for the Basic Dental Implant SystemBasic Dental Implant Systems, Inc. · 2002

Most influential descendants

Showing 4 of 4 · See all
  • K013682Modification to Basic Dental Implant SystemBasic Dental Implant Systems, Inc. · 2001 · cites it directly2descendants
  • K072595Omni-TightBasic Dental Implant Systems, Inc. · 2008 · 2 generations on1descendant
  • K082749Omni-TightBasic Dental Implant Systems, Inc. · 2008 · 3 generations on0descendants
  • K022912Post and Core - Thin for the Basic Dental Implant SystemBasic Dental Implant Systems, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960868B.a.S.I.C. Dental Implant SystemDanlin Products, Inc.1996—
+1K013682Modification to Basic Dental Implant SystemBasic Dental Implant Systems, Inc.2001—
+2K072595Omni-TightBasic Dental Implant Systems, Inc.2008—
+3K082749Omni-TightBasic Dental Implant Systems, Inc.2008—
+1K022912Post and Core - Thin for the Basic Dental Implant SystemBasic Dental Implant Systems, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200820
FIG. 1 — Lineage of K960868, 1996–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013682Modification to Basic Dental Implant SystemBasic Dental Implant Systems, Inc.20012
K022912Post and Core - Thin for the Basic Dental Implant SystemBasic Dental Implant Systems, Inc.20020

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?

  • Of its descendants, K013682 (Basic Dental Implant Systems, Inc., 2001) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K960868 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960868: B.a.S.I.C. Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960868

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026