510(k) · Cleared
ClearedRegular 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 Jul 14, 1999 as substantially equivalent to K894595 (Institut Straumann AG, 1990) and 2 other predicates after a 104-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Jul 14, 1999
- Review
- 104 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894595 (1990). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- This deviceK991114 Regular Diameter Single Stage (RDS) TPS Dental Implant SystemLifecore Biomedical, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK994205 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| 0 (this device) | K991114 | Regular Diameter Single Stage (RDS) TPS Dental Implant System | Lifecore Biomedical, Inc. | 1999 | — |
| +1 | 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 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…m (RDS) GCommon / Usual | Single Stage Dental Implant Name ‘ Classification Endosseous Implant Name Identification of ITI 4.1mm Solid Screw Implant and Accessories (K894595, Equivalent K920768), manufactured by Straumann Dental, and Devices Restore Self-Tapping Implant System (K 924589), manufactured… | 1990 |
| * | K920768 | Hollow Screw Implants 6MM, 14MM, 16MMSummary page 1…sual | Single Stage Dental Implant Name ‘ Classification Endosseous Implant Name Identification of ITI 4.1mm Solid Screw Implant and Accessories (K894595, Equivalent K920768), manufactured by Straumann Dental, and Devices Restore Self-Tapping Implant System (K 924589), manufactured by Lifecore Biomedi… | 1992 |
| * | K924589 | Restore Self Tapping Dental Implant SystemSummary page 1…cation of ITI 4.1mm Solid Screw Implant and Accessories (K894595, Equivalent K920768), manufactured by Straumann Dental, and Devices Restore Self-Tapping Implant System (K 924589), manufactured by Lifecore Biomedical, Inc. 3. Device Description The Regular Diameter Single Stage (RDS) TPS Dental Implant S… | 1994 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Regular Diameter Single Stage TPS Dental Implant System is indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous maxilliary and mandibular arches in areas with sufficient alveolar bone width and helght 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/K991114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991114: 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/K991114
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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