510(k) Report

510(k) · Cleared

Cleared

Kis-Iii Non-Submerged Implant, Screws and Cylinders

K961381510(k) TraditionalCleared Sep 9, 1997539-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

The Emerging Technologies Group · DZE Implant, Endosseous, Root-Form

Cleared on Sep 9, 1997 as substantially equivalent to K902433 (Dental Imaging Assoc., Inc., 1992) and 5 other predicates after a 539-day review. Its family tree reaches back 1 generation to 1991.

Decided
Sep 9, 1997
Review
539 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K902435 (1991). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 3 other ancestors1992: 1 other ancestor1991: 1 other ancestorK902435 · Dia Impression Coping · Dental Imaging Assoc., Inc. · 199119901992199419961998
Other ancestors, by generation 1 generation back: 5 other ancestors K902435 · Dia Impression Coping · Dental Imaging Assoc., Inc. · 19910
  1. Root · 1 generation backK902435 Dia Impression CopingDental Imaging Assoc., Inc. · 1991
  2. This deviceK961381 Kis-Iii Non-Submerged Implant, Screws and CylindersThe Emerging Technologies Group · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902435Dia Impression CopingDental Imaging Assoc., Inc.1991—
0 (this device)K961381Kis-Iii Non-Submerged Implant, Screws and CylindersThe Emerging Technologies Group1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199210
199430
FIG. 1 — Lineage of K961381, 1991–1997Source: 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 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? (6)

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
*K902433Dia Anatomic Abutment
Summary page 1
…vices have been reviewed by CDREI, as well as the Oftice of Compliance, and have received a substantial equivalence letter. CREDITED DEVICES Dental Imaging Associates- K902433, also Dental Imaging Associates-K902434, Dental Imaging Associates-K902435, and Implant Innovations Inc. preangled abutments-K932…
Dental Imaging Assoc., Inc.1992—
*K902434Dia Healing Cap
Summary page 1
…ll as the Oftice of Compliance, and have received a substantial equivalence letter. CREDITED DEVICES Dental Imaging Associates- K902433, also Dental Imaging Associates-K902434, Dental Imaging Associates-K902435, and Implant Innovations Inc. preangled abutments-K932123 Predicate devices for wide body imp…
Dental Imaging Assoc., Inc.1991—
*K902435Dia Impression Coping
Summary page 1
…have received a substantial equivalence letter. CREDITED DEVICES Dental Imaging Associates- K902433, also Dental Imaging Associates-K902434, Dental Imaging Associates-K902435, and Implant Innovations Inc. preangled abutments-K932123 Predicate devices for wide body implants, Nobelpharma K925766, Implant…
Dental Imaging Assoc., Inc.1991—
*K932123Implant Innovation Pre-Angled Abutment System
Summary page 1
…DEVICES Dental Imaging Associates- K902433, also Dental Imaging Associates-K902434, Dental Imaging Associates-K902435, and Implant Innovations Inc. preangled abutments-K932123 Predicate devices for wide body implants, Nobelpharma K925766, Implant Innovations K933462 DEVICE DESCRIPTION Endosseous impla…
Implant Innovations International, Inc.1994—
*K925766Branemark System Temporary Solutions
Summary page 1
…ng Associates-K902434, Dental Imaging Associates-K902435, and Implant Innovations Inc. preangled abutments-K932123 Predicate devices for wide body implants, Nobelpharma K925766, Implant Innovations K933462 DEVICE DESCRIPTION Endosseous implant systém consists of implants, tools and prosthetic abutments.…
Nobelpharma USA, Inc.1994—
*K933462Conical Abutment
Summary page 1
…Imaging Associates-K902435, and Implant Innovations Inc. preangled abutments-K932123 Predicate devices for wide body implants, Nobelpharma K925766, Implant Innovations K933462 DEVICE DESCRIPTION Endosseous implant systém consists of implants, tools and prosthetic abutments. This submission includes pre…
Implant Innovations, Inc.1994—

Also cleared against K902433: 9 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 6 ancestors has a recall.
  • 9 other devices also cite its predicate K902433.

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 NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant patients. The implants are to be used in single or multiple units in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported partial denture, implant supported bar/overdenture, implant retained overdenture, fixed-detachable…

Read the full statement (161 words)

The NSS-nonsubmerged implant system.

These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant patients. The implants are to be used in single or multiple units in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported partial denture, implant supported bar/overdenture, implant retained overdenture, fixed-detachable implant prosthesis, and totally edentulous implant retained prosthetic designs. The diameter changes of the implant system are to correspond with the maximum available bone width in the treatment areas. Large diameter implants can be utilized to engage the greatest amount of bone volume. These implants can also be used in a submerged protocol if the tissue is thick and a short healing cover screw is utilized. The nonsubmerged protocol does not imply immediate loading, and the implants should integrate in a 3-8 month healing phase based on the bone density before prosthetic 1load is incorporated into the implant sites.

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

Also cleared against K902433

9 other devices cite the same predicate.

  • K961385MT-3AThe Emerging Technologies Group · 1996
  • K961387MT-XThe Emerging Technologies Group · 1996
  • K961384MT-2The Emerging Technologies Group · 1996
  • K961386MT-2AThe Emerging Technologies Group · 1996
  • K961383MT1The Emerging Technologies Group · 1996
  • K961382MT1AThe Emerging Technologies Group · 1996

More from The Emerging Technologies Group

7 FDA decisions under this applicant name. See the company

  • K961384MT-2The Emerging Technologies Group · 1996
  • K961383MT1The Emerging Technologies Group · 1996
  • K961385MT-3AThe Emerging Technologies Group · 1996
  • K961387MT-XThe Emerging Technologies Group · 1996
  • K961382MT1AThe Emerging Technologies Group · 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/K961381 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961381: Kis-Iii Non-Submerged Implant, Screws and Cylinders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961381

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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