510(k) Report

510(k) · Cleared

Cleared

Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation Corporation NTR-3.3 MM Self-Tapping HA Coa

K992512510(k) TraditionalCleared Nov 1, 199997-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

Imcor · DZE Implant, Endosseous, Root-Form

Cleared on Nov 1, 1999 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 320 later devices descend from it.

Decided
Nov 1, 1999
Review
97 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

320 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 4 descendants cleared2003: 2 descendants cleared2012: 11 descendants cleared2013: 11 descendants cleared2008: 8 descendants cleared2004: 1 descendant cleared2007: 4 descendants cleared2016: 13 descendants cleared2009: 4 descendants cleared2014: 14 descendants cleared2006: 2 descendants cleared2011: 8 descendants cleared2010: 4 descendants cleared2017: 14 descendants cleared2015: 11 descendants cleared2021: 20 descendants cleared2018: 11 descendants cleared2023: 30 descendants cleared2020: 21 descendants cleared2022: 30 descendants cleared2019: 17 descendants cleared2024: 34 descendants cleared2025: 27 descendants cleared2026: 19 descendants cleared1995200020052010201520202025
  1. This deviceK992512 Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva…Imcor · 1999
  2. Descendant · cites it directly · 313 of its ownK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
  3. Descendant · 2 generations on · 271 of its ownK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
  5. Descendant · 3 generations on · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
  6. Descendant · 4 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013

Showing 5 of 320 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12005: 42006: 22007: 42008: 82009: 42010: 42011: 82012: 112013: 112014: 142015: 112016: 132017: 142018: 112019: 172020: 212021: 202022: 302023: 302024: 342025: 272026: 19
2003high 34 (2024) · low 1 (2004)2026

Most influential descendants

Showing 5 of 320 · See all
  • K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003 · cites it directly313descendants
  • K041938Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · 2 generations on271descendants
  • K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · 2 generations on187descendants
  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · 3 generations on141descendants
  • K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 4 generations on127descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992512Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation…Imcor1999—
+1K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc.2003—
+2K041938Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc.20042
+2K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007—
+3K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
200540
200620
200740
200880
200940
201040
201180
2012110
2013110
2014140
2015110
2016130
2017140
2018110
2019170
2020210
2021200
2022300
2023300
2024340
2025270
2026190
FIG. 1 — Lineage of K992512, 1999–2026Source: 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), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (320)

See all 320

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

NumberDeviceApplicantDecidedDescendants
K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc.2003313
K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.200543
K033392Immediate Stabilizing Implant (Isi)O Co., Inc.20035

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, K032351 (BioHorizons Implant Systems, Inc., 2003) has gone furthest, with 313 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—

What is it indicated for?

The Altiva implant sizes are for widths 3.3mm, 4.00mm, and 5.00mm. All widths come in lengths of 10mm, 11.5mm, 13mm and 15mm.

Altiva implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The Altiva implants can be placed with or without issue reflection.

The Altiva Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The Altiva Implant is designed to be placed in immediate function with a temporary.

All components are to be used as labeled. Components are not intended to be bent by the clinician.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Imcor

7 FDA decisions under this applicant name. See the company

  • K983563Imcor 4.00 & 5.00MM Self-Tapping Locktite Implants, Imcor 4.00 & 5.00MM Self-Tapping HA Coasted Locktite…Imcor · 1999
  • K982492Imcor Dental Implant System AccessoriesImcor · 1998
  • K974126Imcor 3.75 and 5.00MM Externally Hexed, Self Tapping HA Coated Screw Implants with Cover ScrewImcor · 1998
  • K973049Imcor Externally Hexed, Self-Tapping Screw Implant Surgical Drilling SystemImcor · 1997
  • K960899Imcor 5.00 MM Hex Self-Tapping Screw W/Cover ScrewImcor · 1996

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/K992512 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992512: Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation Corporation NTR-3.3 MM Self-Tapping HA Coa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992512

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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