510(k) Report

510(k) · Cleared

Cleared

Almitech Inc. Dental Implant System

K052733510(k) TraditionalCleared Dec 22, 200584-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

Almitech, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Dec 22, 2005 as substantially equivalent to K894593 (Institut Straumann AG, 1990) and 6 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1986.

Decided
Dec 22, 2005
Review
84 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K861426 (1986). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1992: 1 other ancestor1990: 2 other ancestorsK861426 · Screw-Vent (TM) Implant/Endosseous Screw Implant · Core-Vent Corp. · 198619851990199520002005
Other ancestors, by generation 1 generation back: 6 other ancestors K861426 · Screw-Vent (TM) Implant/Endosseous Screw Implant · Core-Vent Corp. · 19860
  1. Root · 1 generation backK861426 Screw-Vent (TM) Implant/Endosseous Screw ImplantCore-Vent Corp. · 1986
  2. This deviceK052733 Almitech Inc. Dental Implant SystemAlmitech, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K861426Screw-Vent (TM) Implant/Endosseous Screw ImplantCore-Vent Corp.1986—
0 (this device)K052733Almitech Inc. Dental Implant SystemAlmitech, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199210
199510
199710
200110
FIG. 1 — Lineage of K052733, 1986–2005Source: 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? (7)

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
*K894593Bonefit Hollow Cylinder Implants
Summary page 2
…ices: The data submitted in this 510(K) is aimed toward demonstrating substantial equivalence of Almitech Inc. Dental Implant System to ITI Solid screw implant (K894593), (K894595), (K971578), (1(920768), Blue Sky Bio Dental Implant System (K010882), and Paragon Screw-Vent System (K950578), (K8614…
Institut Straumann AG1990—
*K894595Bonefit R Screw Implants
Summary page 2
…The data submitted in this 510(K) is aimed toward demonstrating substantial equivalence of Almitech Inc. Dental Implant System to ITI Solid screw implant (K894593), (K894595), (K971578), (1(920768), Blue Sky Bio Dental Implant System (K010882), and Paragon Screw-Vent System (K950578), (K861426). Almite…
Institut Straumann AG1990—
*K971578Endosseous Dental Implant
Summary page 2
…a submitted in this 510(K) is aimed toward demonstrating substantial equivalence of Almitech Inc. Dental Implant System to ITI Solid screw implant (K894593), (K894595), (K971578), (1(920768), Blue Sky Bio Dental Implant System (K010882), and Paragon Screw-Vent System (K950578), (K861426). Almitech Inc. Den…
Straumann USA1997—
*K920768Hollow Screw Implants 6MM, 14MM, 16MM
Summary page 3
…, System K861426 K971578, and K010882 K920768 Material CP Titanium CP Titanium CP Titanium CP Titanium Grade…
The Straumann Co.1992—
*K010882Blue Sky Bio Dental Implant System
Summary page 2
…ubstantial equivalence of Almitech Inc. Dental Implant System to ITI Solid screw implant (K894593), (K894595), (K971578), (1(920768), Blue Sky Bio Dental Implant System (K010882), and Paragon Screw-Vent System (K950578), (K861426). Almitech Inc. Dental Implant System is compatible to the three Dental Impla…
Blue Sky Bio2001—
*K950578Screw-Vent Implant
Summary page 2
…ental Implant System to ITI Solid screw implant (K894593), (K894595), (K971578), (1(920768), Blue Sky Bio Dental Implant System (K010882), and Paragon Screw-Vent System (K950578), (K861426). Almitech Inc. Dental Implant System is compatible to the three Dental Implant Systems examined above and all contain…
Core-Vent Corp.1995—
*K861426Screw-Vent (TM) Implant/Endosseous Screw Implant
Summary page 2
…nt System to ITI Solid screw implant (K894593), (K894595), (K971578), (1(920768), Blue Sky Bio Dental Implant System (K010882), and Paragon Screw-Vent System (K950578), (K861426). Almitech Inc. Dental Implant System is compatible to the three Dental Implant Systems examined above and all contain implants,…
Core-Vent Corp.1986—

Also cleared against K894593: 3 other devices →

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?

  • None of the 7 ancestors has a recall.
  • 3 other devices also cite its predicate K894593.

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 implant system is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain over dentures by means of o-ring abutments or bar-attachments

Indications for use as stated in the FDA summary.

Also cleared against K894593

3 other devices cite the same predicate.

  • K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
  • K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
  • K983742Iti Dental Implant SystemInstitut Straumann AG · 1999

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/K052733 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052733: Almitech Inc. 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/K052733

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 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026