510(k) · Cleared
Cleared3Shape Abutment Designer Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Shape A/S · PNP Dental Abutment Design Software For Dental Laboratory
Cleared on Sep 6, 2016 as substantially equivalent to K100152 (Sirona Dental Systems GmbH, 2010) after a 463-day review. Its family tree reaches back 10 generations to 1990. 10 later devices descend from it.
- Decided
- Sep 6, 2016
- Review
- 463 days
- Class
- Class II
- Product code
- PNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894844 (1990). 116 ancestors in all, the oldest K871863 (1987). 10 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations between
- 3 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 2 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 1 generation backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- This deviceK151455 3Shape Abutment Designer Software3Shape A/S · 2016
- Descendant · cites it directly · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK200100 Abutment Design3Shape A/S · 2020
- Descendant · 2 generations on · 0 of its ownK233252 Straumann CARES Visual and Nova Dental CADInstitut Straumann AG · 2024
- Descendant · 2 generations on · 0 of its ownK231529 CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK230873 Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 8 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 7 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 6 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 5 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 4 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 3 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 2 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 1 generation backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- This deviceK151455 3Shape Abutment Designer Software3Shape A/S · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · cites it directly3descendants
- K200100Abutment Design3Shape A/S · 2020 · cites it directly3descendants
- K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG · 2024 · 2 generations on0descendants
- K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc. · 2024 · 2 generations on0descendants
- K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −9 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −8 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −7 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −6 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −5 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −4 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −3 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −2 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −1 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| 0 (this device) | K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016 | — |
| +1 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K200100 | Abutment Design | 3Shape A/S | 2020 | — |
| +2 | K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | 2024 | — |
| +2 | K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | 2024 | — |
| +2 | K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 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 PNP? 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 PNP device
- #1 K200100 Abutment Designscore 12.1 · 11 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 |
|---|---|---|---|
| * | K100152 | Sirona Cad/Cam SystemSummary page 4…Number: 872.3630 C Classification: Class II D Product Code: PNP Predicate Device Sirona Dental CAD/CAM System (K100152). Intended Use The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partiall… | 2010 |
What descends from it? (10)
4 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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 15 of the 116 ancestors have a recall of any class.
- Of its descendants, K193084 (Southern Implants (Pty), Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K100152.
How does its category compare?
All PNP devicesPNP Dental Abutment Design Software For Dental Laboratory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PNP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PNP
Too few PNP 510(k)s in any year since 2007 to give a median.
Recalls per year · PNP
No recall names PNP since 2007.
Adverse event reports per year · PNP
No MAUDE report names PNP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer Software is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, one-piece, or hybrid dental implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
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/K151455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151455: 3Shape Abutment Designer Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151455
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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