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 Aug 11, 2016 as substantially equivalent to K142211 (Rhein'83 Srl, 2015) after a 183-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Aug 11, 2016
- Review
- 183 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950260 (1997). 3 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 | K950260 | Quick Coupling Device for Dental Prostheses | Dr. Joseph E. Grasso, D.D.S. | 1997 | — |
| −1 | K142211 | OT Equator | Rhein'83 Srl | 2015 | — |
| 0 (this device) | K160382 | OT Equator | Rhein'83 Srl | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 30.7 · 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? (1)
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 |
|---|---|---|---|
| * | K142211 | OT EquatorSummary page 5…NHA Panel: Dental Predicate Devices Predicate : OT Equator (K142211) DEVICE DESCRIPTION The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdent… | 2015 |
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 19 years and passes through 2 companies; a new generation was cleared every 18.2 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K142211.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 following implant systems: NOBEL BIOCARE AB - NobelActive NP 3.5 NOBEL BIOCARE AB - NobelActive RP 4,3 - 5 NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5 NOBEL BIOCARE USA INC - Replace Select…
Read the full statement (363 words)
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 following implant systems:
NOBEL BIOCARE AB - NobelActive NP 3.5
NOBEL BIOCARE AB - NobelActive RP 4,3 - 5
NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5
NOBEL BIOCARE USA INC - Replace Select Straight TiUnit RP 4.3
NOBEL BIOCARE USA LLC - Replace Select Straight TiUnit WP 5
NOBEL BIOCARE AB - Brénemark System Mk III TiUnite NP 3.3
NOBEL BIOCARE AB - Branemark System Mk III Shorty RP 4,1
NOBEL BIOCARE AB - Branemark System Mk III TiUnite WP5 6
Straumann USA - Bone level NC 3.3
Straumann USA - Bone level RC 4.1 —4.8
Straumann USA - Tissue level RN 4,8
Straumann USA - Tissue level WN 6,5
Zimmer Dental Inc. - Tapered Screw-Vent 3.5, 4.5, 5.7
Zimmer Dental Inc. - Spline 3.25, 3.75-4, 5
ASTRA TECH AB - OsseoSpeed™ TX 3.5-4, 4.5-5
DENTSPLY INTL., INC. - ANKYLOS C/ 3,5
DENTSPLY INTERNATIONAL, INC. - FRIALIT plus Stepped Screw 3.4, 3.8, 4.5, 5.5, 6.5
BIOMET 3i - Certain 3.25, 4.1, 5, 6
IMPLANT DIRECT LLC - Legacy 3, 3.75, 4.7
IMPLANT DIRECT LLC - Tri-Lobe 3.5,4.3,5-6
IMPLANT DIRECT LLC - Tri-Lobe 3.5,4.3,5-6
IMPLANT DIRECT SYBRON MANUFACTURING LLC - Swish Plus3.7, 4.1 — 4.8
MIS - IMPLANT TECHNOLOGIES LTD. - SEVEN 3.3, 3.75,4.2, 5, 6
MIS - IMPLANT TECHNOLOGIES LTD. - C1 3.3, 3.75,3.9,4.2,4.3, 5
MEGAGEN CO., LTD. - ANYRIDGE 3.5, 4,4.5, 5, 5.5
NEODENT USA, INC. - CM Titamax 3.5, 3.75, 4,4.3, 5
NEODENT USA, INC. - CM Drive 3.5, 3.75, 4,4.3, 5
NEOSS, LTD. - ProActive 3.5, 4, 4.5, 5, 5.5, 6
BIOHORIZONS IMPLANT SYSTEMS, INC. - Laser-lok® 3.0
BIOHORIZONS IMPLANT SYSTEMS, INC. - Tapered internal 3.5, 4.5, 5.7
KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM SD 3.5
KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM RD 4.1
KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM WD 5
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/K160382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160382: OT Equator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160382
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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