510(k) · Cleared
ClearedInclusive Implant Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inclusive Dental Solutions · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 14, 2008 as substantially equivalent to K063341 (Implant Innovations, Inc., 2007) and 6 other predicates after a 181-day review. Its family tree reaches back 9 generations to 1993. 3 later devices descend from it.
- Decided
- May 14, 2008
- Review
- 181 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K925765 (1993). 103 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK073217 Inclusive Implant AbutmentsInclusive Dental Solutions · 2008
- Descendant · cites it directly · 2 of its ownK142115 Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and…Prismatik Dentalcraft, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK151295 Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015
- Descendant · 3 generations on · 0 of its ownK231210 DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- This deviceK073217 Inclusive Implant AbutmentsInclusive Dental Solutions · 2008
Most influential descendants
Showing 3 of 3 · See all- K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc. · 2014 · cites it directly2descendants
- K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015 · 2 generations on1descendant
- K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| 0 (this device) | K073217 | Inclusive Implant Abutments | Inclusive Dental Solutions | 2008 | — |
| +1 | K142115 | Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel… | Prismatik Dentalcraft, Inc. | 2014 | 1 |
| +2 | K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | 2015 | — |
| +3 | K231210 | DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. | 2024 | — |
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 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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? (7)
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 |
|---|---|---|---|
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 1…l Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439). Safety and Efficacy: The device functions in… | 2007 |
| * | K072642 | Biomet 3I Dental Abutments and Restorative Components Cleared while this submission was under review Summary page 1…ence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439). Safety and Efficacy: The device functions in a simila… | 2007 |
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 1…antially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439). Safety and Efficacy: The device functions in a similar manner to other compara… | 2004 |
| * | K022425 | ScrewlineSummary page 1…equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439). Safety and Efficacy: The device functions in a similar manner to other comparative devi… | 2002 |
| * | K041275 | Procera Abutment OctagonSummary page 1…t to other legally marketed devices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439). Safety and Efficacy: The device functions in a similar manner to other comparative devices and t… | 2004 |
| * | K061847 | Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452SSummary page 1…keted devices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439). Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the… | 2006 |
| * | K071439 | Zimmer Patient-Specific Abutment, Internal Hex, TitaniumSummary page 1…ices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439). Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. Th… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142115 | Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant | 2014 | 2 |
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 15 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 13 of the 103 ancestors have a recall of any class.
- Of its descendants, K142115 (Prismatik Dentalcraft, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K063341.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Inclusive Abutment is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The…
Read the full statement (165 words)
The Inclusive Abutment is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 31 Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internal-connection implants.
Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073217 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073217: Inclusive Implant Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073217
Report an extraction error
Are you the manufacturer?
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