510(k) · Cleared
ClearedRodo Abutment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rodo Medical, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 27, 2020 as substantially equivalent to K160786 (Rodo Medical, Inc., 2016) after a 93-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Feb 27, 2020
- Review
- 93 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894595 (1990). 152 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK160786 RODO Abutment SystemRodo Medical, Inc. · 2016
- This deviceK193274 Rodo Abutment SystemRodo Medical, Inc. · 2020
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 5 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK160786 RODO Abutment SystemRodo Medical, Inc. · 2016
- This deviceK193274 Rodo Abutment SystemRodo Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −9 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −8 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −7 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −6 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −5 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −1 | K160786 | RODO Abutment System | Rodo Medical, Inc. | 2016 | — |
| 0 (this device) | K193274 | Rodo Abutment System | Rodo Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K160786 | RODO Abutment SystemSummary page 4…Name: Endosseous dental implant abutment Regulation Number: 21 CFR 872.3630 Class: Class II Product Code: NHA Primary Predicate Device Rodo Medical Abutment System, K160786 Reference Devices Biomet Certain Internal Connection Implants, K122300, K062636, K063286, K063341, K061629, K100724, K111216 B… | 2016 |
| † | K122300 | T3 Dental Implant | 2013 |
| † | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | 2007 |
| † | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K061629 | Certain Prevail Dental Implant | 2007 |
| † | K100724 | Osseotite II Model Xifossxxx | 2011 |
| † | K111216 | Osseotite 2 Dental Implants | 2011 |
| † | K121787 | Biohorizons Tapered Internal Plus Implants | 2012 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K073268 | Biohorizons Internal Implant System | 2008 |
| † | K143022 | BioHorizons Tapered Internal Implants | 2015 |
| † | K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 152 ancestors have a recall of any class.
- 1 other device also cites its predicate K160786.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures. Compatible Systems Implant Line | OEM Platform Size | OEM Body Size Straumann Bone Level | NC, RC | 3.3, 4.1, 4.8 Neodent Drive CM | 3.5, 4.3, 5.0 | 3.5, 4.3, 5.0 Neodent Titamax CM | 3.5, 3.75, 4.0, 5.0 | 3.5, 3.75, 4.0, 5.0 Neodent Alvim CM | 3.5, 4.3, 5.0 | 3.5, 4.3, 5.0…
Read the full statement (181 words)
Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.
Compatible Systems
Implant Line | OEM Platform Size | OEM Body Size
Straumann Bone Level | NC, RC | 3.3, 4.1, 4.8
Neodent Drive CM | 3.5, 4.3, 5.0 | 3.5, 4.3, 5.0
Neodent Titamax CM | 3.5, 3.75, 4.0, 5.0 | 3.5, 3.75, 4.0, 5.0
Neodent Alvim CM | 3.5, 4.3, 5.0 | 3.5, 4.3, 5.0
NobelActive | 3.0, NP, RP, WP | 3.0, 3.5, 4.3, 5.0, 5.5
Nobel Replace Conical | NP, RP | 3.5, 4.3, 5.0
NobelReplace Straight | NP, RP, WP | 3.5, 4.0, 5.0
NobelReplace Tapered | NP, RP, WP, 6.0 | 3.5, 4.3, 5.0, 6.0
NobelSpeedy Replace | NP, RP, WP, 6.0 | 3.5, 4.0, 5.0, 6.0
Biohorizons Tapered Internal | 3.0, 3.5, 4.5, 5.7 | 3.0, 3.4, 3.8, 4.6, 5.8
Biomet 3i Certain Internal | 3.4, 4.1, 5.0, 6.0 | 3.25, 3.4, 4.1, 5.0, 6.0
Neodent GM | 3.5 | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193274: Rodo Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193274
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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