510(k) · Cleared
ClearedOT Equator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhein'83 Srl · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 25, 2015 as substantially equivalent to K033630 (Rhein 83 Srl, 2004) and 1 other predicate after a 470-day review. Its family tree reaches back 1 generation to 1997. 13 later devices descend from it.
- Decided
- Nov 25, 2015
- Review
- 470 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950260 (1997). 2 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK950260 Quick Coupling Device for Dental ProsthesesDr. Joseph E. Grasso, D.D.S. · 1997
- This deviceK142211 OT EquatorRhein'83 Srl · 2015
- Descendant · cites it directly · 7 of its ownK163060 Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 2 of its ownK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK171694 s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017 · cites it directly7descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · 2 generations on2descendants
- K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017 · cites it directly2descendants
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950260 | Quick Coupling Device for Dental Prostheses | Dr. Joseph E. Grasso, D.D.S. | 1997 | — |
| 0 (this device) | K142211 | OT Equator | Rhein'83 Srl | 2015 | — |
| +1 | K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | 2017 | — |
| +2 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +1 | K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | 2017 | — |
| +3 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K033630 | Modification of: Sphero Flex, Pivot Flex, and Sphero BlockSummary page 5…NHA Panel: Dental Predicate Devices Primary Predicate : -Sphero Flex, Sphero Block, Pivot Flex (K033630) Reference Predicates: - Quick Coupling For Dental Prostheses (K950260) -Device For Providing Quick Coupling For Den… | 2004 |
| * | K950260 | Quick Coupling Device for Dental ProsthesesSummary page 5…ental Predicate Devices Primary Predicate : -Sphero Flex, Sphero Block, Pivot Flex (K033630) Reference Predicates: - Quick Coupling For Dental Prostheses (K950260) -Device For Providing Quick Coupling For Dental Prostheses (K950260) DEVICE DESCRIPTION The OT Equator Implant Anchor abu… | 1997 |
What descends from it? (13)
See all 134 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K163060 (Southern Implants (Pty), Ltd., 2017) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
The OT Equator abutments are indicated for use with the implant systems listed in Attachment B.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142211: OT Equator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142211
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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