510(k) · Cleared
ClearedIPDmilled Blanks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Protesis Dental 2004, S.L. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 22, 2026 as substantially equivalent to K240982 (Terrats Medical SL, 2024) after a 115-day review. Its family tree reaches back 21 generations to 1996.
- Decided
- Jan 22, 2026
- Review
- 115 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K960026 (1996). 326 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations between
- 3 generations backK203464 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- 2 generations backK222288 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- 1 generation backK240982 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- This deviceK253253 IPDmilled BlanksImplant Protesis Dental 2004, S.L. · 2026
Show all 21 generations
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 20 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 19 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 18 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 17 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 16 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 14 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 13 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 12 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 11 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 10 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 9 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 8 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 7 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 6 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 5 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 4 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 3 generations backK203464 DESS Dental Smart SolutionsTerrats Medical SL · 2021
- 2 generations backK222288 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- 1 generation backK240982 DESS Dental Smart SolutionsTerrats Medical SL · 2024
- This deviceK253253 IPDmilled BlanksImplant Protesis Dental 2004, S.L. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −20 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −19 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −18 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −17 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −16 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −14 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −13 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −12 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −11 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −10 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −9 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −8 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −7 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −6 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −5 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −4 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −3 | K203464 | DESS Dental Smart Solutions | Terrats Medical SL | 2021 | — |
| −2 | K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| −1 | K240982 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 | — |
| 0 (this device) | K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026 | — |
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 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 24 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K240982 | DESS Dental Smart SolutionsSummary page 7…Regulatory Class: Class II Product Code(s): Primary: NHA; Secondary: PNP. III. PREDICATE DEVICE(S): Primary Predicate: K240982, DESS Dental Smart Solutions Reference Devices: K151455, 3Shape Abutment Designer™ Software,… | 2024 |
| † | K151455 | 3Shape Abutment Designer Software | 2016 |
| † | K193352 | AbutmentCAD | 2021 |
| † | K041368 | Dentium CO., LTD. Implantium | 2004 |
| † | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems | 2008 |
| † | K083561 | Neoss Proactive Implant | 2009 |
| † | K090154 | Spi Dental Implant Inicell | 2009 |
| † | K090716 | Bego Semados S-Line | 2009 |
| † | K112162 | Conical Connection Implants | 2012 |
| † | K140347 | Ankylos C/X Implant System | 2014 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K180365 | PRAMA White Implant Systems | 2019 |
| † | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | 2020 |
| † | K200586 | Straumann TLX Implant System | 2020 |
| † | K213997 | Kontact Dental Implant System | 2022 |
| † | K231566 | ICX-Implant System | 2024 |
| † | K240187 | Tapered Pro Conical Implant System | 2024 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K130222 | Straumann Dental Implant System | 2013 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K101732 | Astra Tech Implant System | 2011 |
| † | K112160 | Tapered Screw-Vent X Implant | 2011 |
| † | K180282 | MIS Internal Hex Dental Implant System | 2018 |
| † | K142260 | NobelActive | 2015 |
| † | K161604 | OSSTEM Implant System | 2016 |
| † | K140091 | Xpeed Anyridge Internal Implant Sysyem | 2014 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K022425 | Screwline | 2002 |
| † | K023113 | Replace Tiunite Endosseous Implant | 2002 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K191256 | Straumann BLX Ø3.5 mm Implants | 2019 |
| † | K173961 | Straumann BLX Implant System | 2018 |
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 8 companies; a new generation was cleared every 11 months on median.
- 44 of the 326 ancestors have a recall of any class.
- 2 other devices also cite its predicate K240982.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
IPDmilled Blanks are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed CAD/CAM customizations for the IPDmilled Blanks are to be designed and manufactured according to digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. The workflow system integrates multiple components of the digital…
Read the full statement (234 words)
IPDmilled Blanks are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed CAD/CAM customizations for the IPDmilled Blanks are to be designed and manufactured according to digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
Compatible Implant Systems
Dentium Co., Ltd Implantium
Friadent Implant Systems
Neoss ProActive Implant
SPI® Dental Implant, Inicell®
BEGO Semados® S-Line
ANKYLOS® C/X Implant System
MIS V3 Conical Connection Dental Implant System
Conical Connection Implants (MIS® C1)
MIS C1 Narrow Platform Conical Connection Implant System
MIS C1 Wide Platform Conical Connection Abutments
PRAMA White Implant Systems
Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants
Straumann TLX Implant System
Kontact Dental Implant System
ICX-Implant System
Tapered Pro Conical Implant System
Straumann® Tissue Level
Zimmer Tapered Screw-Vent®
Nobel Biocare® Nobel Active®
Straumann® Bone Level Tapered Implants
Neodent Implant System – GM Line
Osstem Implant System
Xpeed AnyRidge Internal Implant System
3i Osseotite® Certain® Dental Implants
Astra Tech Implant System (Osseospeed®)
OsseoSpeed™ Plus
BioHorizons Tapered Internal Implant System
MIS Internal Hex Dental Implant System (MIS® Seven®)
Straumann BLX Ø3.5 mm Implants
Straumann® BLX Implant System
ALTATEC Camlog Screwline Implant System
Replace TiUnite Endosseous Implant
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253253: IPDmilled Blanks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253253
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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