510(k) · Cleared
ClearedModification of Regular Diameter Single Stage (RDS) TPS Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 29, 2000 as substantially equivalent to K894595 (Institut Straumann AG, 1990) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Feb 29, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K894595 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 1 generation backK991114 Regular Diameter Single Stage (RDS) TPS Dental Implant SystemLifecore Biomedical, Inc. · 1999
- This deviceK994205 Modification of Regular Diameter Single Stage (RDS) TPS Dental…Lifecore Biomedical, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK053643 Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc. · 2006 · cites it directly0descendants
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 | K991114 | Regular Diameter Single Stage (RDS) TPS Dental Implant System | Lifecore Biomedical, Inc. | 1999 | — |
| 0 (this device) | K994205 | Modification of Regular Diameter Single Stage (RDS) TPS Dental Implant System | Lifecore Biomedical, Inc. | 2000 | — |
| +1 | K053643 | Stage- 1 Temporary/Healing Cap, Model 42021-42026 | Lifecore Biomedical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K894595 | Bonefit R Screw ImplantsSummary page 1…ngle Stage Dental Implant Name Classification Name Endosseous Implant Identification of e [Tl 4.1mm and 4.8mm Solid Screw Implant and Accessories Equivalent Devices (K894595, K920768), manufactured by Straumann Dental, ¢ Regular Diameter Single Stage TPS Dental Implant System (K991114) by Lifecore Bio… | 1990 |
| * | K920768 | Hollow Screw Implants 6MM, 14MM, 16MMSummary page 1…e Dental Implant Name Classification Name Endosseous Implant Identification of e [Tl 4.1mm and 4.8mm Solid Screw Implant and Accessories Equivalent Devices (K894595, K920768), manufactured by Straumann Dental, ¢ Regular Diameter Single Stage TPS Dental Implant System (K991114) by Lifecore Biomedical,… | 1992 |
| * | K991114 | Regular Diameter Single Stage (RDS) TPS Dental Implant SystemSummary page 1…d Certification [As required by 21 CFR 807.92(c)] Note: With the exception of the Identification of Equivalent Devices, this section is identical to the original 510(k)(K991114) or the Add-to-File submitted November 30, 1999 (Section 9: Compatibility Testing). 1. Submitter’s Name / Contact Person Caroly… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053643 | Stage- 1 Temporary/Healing Cap, Model 42021-42026 | 2006 | 0 |
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 10 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K053643 (Lifecore Biomedical, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K894595.
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 Stage-1™ Regular Diameter Single Stage TPS Dental Implant System is indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous maxillary and mandibular arches in areas with sufficient alveolar bone width and height to surround the submerged portion of the implant with at least 1mm of bone, both buccally and lingually.
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/K994205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994205: Modification of Regular Diameter Single Stage (RDS) TPS Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994205
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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