510(k) Report

510(k) · Cleared

Cleared

HG II Short Fixture System

K091678510(k) TraditionalCleared Feb 18, 2010253-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

Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form

Cleared on Feb 18, 2010 after a 253-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 66 later devices descend from it.

Decided
Feb 18, 2010
Review
253 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 2 descendants cleared2024: 12 descendants cleared2014: 2 descendants cleared2017: 5 descendants cleared2015: 1 descendant cleared2020: 6 descendants cleared2023: 15 descendants cleared2016: 4 descendants cleared2022: 4 descendants cleared2019: 2 descendants cleared2026: 5 descendants cleared2021: 2 descendants cleared2025: 4 descendants cleared2018: 2 descendants cleared2010201520202025
  1. This deviceK091678 HG II Short Fixture SystemOsstem Implant Co., Ltd. · 2010
  2. Descendant · cites it directly · 64 of its ownK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
  3. Descendant · 2 generations on · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
  4. Descendant · 2 generations on · 38 of its ownK161689 OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · Recalled
  5. Descendant · 2 generations on · 32 of its ownK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
  6. Descendant · 3 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2013: 22014: 22015: 12016: 42017: 52018: 22019: 22020: 62021: 22022: 42023: 152024: 122025: 42026: 5
2013high 15 (2023) · low 1 (2015)2026

Most influential descendants

Showing 5 of 66 · See all
  • K121585TS Implant SystemOsstem Implant Co., Ltd. · 2013 · cites it directly64descendants
  • K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 2 generations on44descendants
  • K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · 2 generations on38descendants
  • K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017 · 2 generations on32descendants
  • K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 3 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K091678HG II Short Fixture SystemOsstem Implant Co., Ltd.2010—
+1K121585TS Implant SystemOsstem Implant Co., Ltd.2013—
+2K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.2014—
+2K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.20172
+2K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.2017—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201420
201510
201640
201750
201820
201920
202060
202120
202240
2023150
2024120
202540
202650
FIG. 1 — Lineage of K091678, 2010–2026Source: 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? (66)

See all 66

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

NumberDeviceApplicantDecidedDescendants
K121585TS Implant SystemOsstem Implant Co., Ltd.201364
K123471Etii SA Fixture SystemHiossen, Inc.201314

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, K121585 (Osstem Implant Co., Ltd., 2013) has gone furthest, with 64 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. 2010, this device’s year, is highlighted.

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 HG II Short Fixture System is indicated for use in partially or filly edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The HG II Short Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Indications for use as stated in the FDA 510(k) statement.

More from Osstem Implant Co., Ltd.

68 FDA decisions under this applicant name. See the company

  • K251434Healing Abutment SystemOsstem Implant Co., Ltd. · 2026
  • K251569Bone ScrewOsstem Implant Co., Ltd. · 2025
  • K242521Estar-ZEOsstem Implant Co., Ltd. · 2024
  • K233806T2 PlusOsstem Implant Co., Ltd. · 20241 recall
  • K233194TS Abutment SystemOsstem Implant Co., Ltd. · 2024

Recent decisions in DZE

The DZE category page

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  • 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/K091678 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091678: HG II Short Fixture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091678

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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