510(k) · Cleared
ClearedAllfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System, Long Neck, Model Sti RT LN Length
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Ihde Dental AG Switzerland · DZE Implant, Endosseous, Root-Form
Cleared on Aug 15, 2001 as substantially equivalent to K983742 (Institut Straumann AG, 1999) and 1 other predicate after an 811-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Aug 15, 2001
- Review
- 811 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894595 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −1 | K955281 | Endosseous Dental Implant & Accessories | The Straumann Co. | 1996 | — |
| 0 (this device) | K991822 | Allfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System… | Dr. Ihde Dental AG Switzerland | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
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 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983742 | Iti Dental Implant SystemSummary page 1…mplant (21 CFR 872.3640, Class III device). 3. Predicate Device: Legally Marketed Devices to which Significant Equivalence SE is claimed: e ITI Dental Implant System® (K983742) ITI Wide diameter Implant (K955281) 4. Intended use of the device The Allfit® STI implants are screw type endosseous dental im… | 1999 |
| * | K955281 | Endosseous Dental Implant & AccessoriesSummary page 1…evice). 3. Predicate Device: Legally Marketed Devices to which Significant Equivalence SE is claimed: e ITI Dental Implant System® (K983742) ITI Wide diameter Implant (K955281) 4. Intended use of the device The Allfit® STI implants are screw type endosseous dental implants made of commercially pure CP… | 1996 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 12 ancestors has a recall.
- 6 other devices also cite its predicate K983742.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The Allfit® STI implants are screw type endosseous dental implants made of commercially pure CP Titanium Grade 4. Provided the existence of adequate bone supply in terms of bone quality, bone width and height, Allfit® STI implants can be used for all indications requiring oral endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws. The restoration may comprise: Single teeth replacement for…
Read the full statement (347 words)
The Allfit® STI implants are screw type endosseous dental implants made of commercially pure CP Titanium Grade 4. Provided the existence of adequate bone supply in terms of bone quality, bone width and height, Allfit® STI implants can be used for all indications requiring oral endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws. The restoration may comprise:
Single teeth replacement for gaps up to the width of Incisive and Premolars
Bridge substitution in edentulous, partially or fully dentate jaws
Bracing for orthodontist regulation systems
Providing retention and support for dentures through bars and/or ball attachment
The implants must be used only in conjunction with the associated original components and instruments of the system according to the indications and recommendations of Dr. Thde Dental AG. The surgical procedures must be preceded by a comprehensive and thorough patient evaluation, preoperative diagnostics, and treatment planning.
Indications for 3.3 mm & STI implants:
STI screw implants with an external diameter of 3.3 mm are considered options for placement in alveolar ridges of limited width (5-6 mm). Since the 3.3 mm diameter STI implants exhibit lower mechanical strength values compared to the 4.1 mm and 4.8 & STI implants, the 3.3 mm diameter screw implants should only be used for indications involving minimal loading.
Indications for 4.8 mm I STI implants:
4.8 mm & STI screw implants can be used for all indications requiring oral, endosseous implants for functional, aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws with a width of 7 mm or more.
It is recommended to always use the longest and widest (diameter) implant. Hereby the possibly influencing forces must be taken into account. It is therefore recommended, not to use implants with small diameters in the posterior side for single teeth implantation. The anatomical and prosthetic conditions have to be taken into consideration.
For a proper use of the STI implants, the consultation of The Allfit® STI instructions for use, provided by Dr. Ihde Dental AG, including the list of absolute, relative and local contraindications, is absolutely indispensable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991822: Allfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System, Long Neck, Model Sti RT LN Length.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991822
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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