510(k) Report

510(k) · Cleared

Cleared

Modification to: Straight Post and Core II for the Basic Dental Implant System

K012299510(k) SpecialCleared Aug 1, 200112-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

Basic Dental Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Aug 1, 2001 as substantially equivalent to K001259 (Basic Dental Implant Systems, Inc., 2001) after a 12-day review. Its family tree reaches back 1 generation to 2001.

Decided
Aug 1, 2001
Review
12 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001259 (2001). No later device cites it as a predicate yet.

K001259 · 2-Piece Post and Core for the B.a.S.I.C. Dental Implant System · Basic Dental Implant Systems, Inc. · 200120002002
K001259 · 2-Piece Post and Core for the B.a.S.I.C. Dental Implant System · Basic Dental Implant Systems, Inc. · 20010
  1. Root · 1 generation backK001259 2-Piece Post and Core for the B.a.S.I.C. Dental Implant SystemBasic Dental Implant Systems, Inc. · 2001
  2. This deviceK012299 Modification to: Straight Post and Core II for the Basic Dental…Basic Dental Implant Systems, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K0012592-Piece Post and Core for the B.a.S.I.C. Dental Implant SystemBasic Dental Implant Systems, Inc.2001—
0 (this device)K012299Modification to: Straight Post and Core II for the Basic Dental Implant SystemBasic Dental Implant Systems, Inc.2001—
FIG. 1 — Lineage of K012299, 2001–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K0012592-Piece Post and Core for the B.a.S.I.C. Dental Implant System
Summary page 1
…ASIC Dental Implant System Straight Post and Core 1I Attachment Accessory to a Dental Implant DZE BASIC Dental Implant System 2-Piece Post and Core Attachment K number K001259 The Straight Post and Core 11 Attachment is a three-piece attachment. The top is attached to the base with a hex screw. The bas…
Basic Dental Implant Systems, Inc.2001—

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?

  • Its one ancestor has no recall.

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—

What is it indicated for?

The BASIC Dental Implant System Straight 2-Piece Post and Core Attachment is indicated for attaching artificial teeth to a dental implant.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Basic Dental Implant Systems, Inc.

6 FDA decisions under this applicant name. See the company

  • K082749Omni-TightBasic Dental Implant Systems, Inc. · 2008
  • K072595Omni-TightBasic Dental Implant Systems, Inc. · 2008
  • K022912Post and Core - Thin for the Basic Dental Implant SystemBasic Dental Implant Systems, Inc. · 2002
  • K013682Modification to Basic Dental Implant SystemBasic Dental Implant Systems, Inc. · 2001
  • K0012592-Piece Post and Core for the B.a.S.I.C. Dental Implant SystemBasic Dental Implant Systems, Inc. · 2001

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/K012299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012299: Modification to: Straight Post and Core II for the Basic Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012299

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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