510(k) · Cleared
ClearedInclusive Titanium Abutments compatible with: Hiossen HG Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 7, 2015 as substantially equivalent to K100993 (Prismatik Dentalcraft, Inc., 2010) after a 138-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Oct 7, 2015
- Review
- 138 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K925765 (1993). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 5 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 4 generations backK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
- 3 generations backK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- 2 generations backK081666 Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra…Astra Tech, Inc. · 2008
- 1 generation backK100993 Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc. · 2010
- This deviceK151375 Inclusive Titanium Abutments compatible with: Hiossen HG Implant…Prismatik Dentalcraft, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −6 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −5 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −4 | K062069 | Atlantis Abutment for 3I Micromini Implant | Atlantis Components, Inc. | 2007 | — |
| −3 | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| −2 | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0… | Astra Tech, Inc. | 2008 | — |
| −1 | K100993 | Inclusive Titanium Abutments for Astra Tech Osseospeed Implants | Prismatik Dentalcraft, Inc. | 2010 | — |
| 0 (this device) | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | Prismatik Dentalcraft, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K100993 | Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsSummary page 5…Trade/Proprietary Name: Predicate Device: Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants–510(k)-K100993 Reference Device: HS/HG Prosthetic System–510(k)-… | 2010 |
| † | K100245 | HS/HG Prosthetic System | 2010 |
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 22 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 23 ancestors has a recall.
- 4 other devices also cite its predicate K100993.
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?
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.
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/K151375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151375: Inclusive Titanium Abutments compatible with: Hiossen HG Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151375
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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