# K253253: IPDmilled Blanks

- Pathway: 510(k) (Traditional)
- Applicant: Implant Protesis Dental 2004, S.L.
- Decided: Jan 22, 2026 after 115 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K960026 (1996). 326 ancestors in all.
No later device cites it as a predicate yet.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240982: DESS Dental Smart Solutions, Terrats Medical SL (2024) Summary page 7.

## Indications for use
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

Source page: https://510kreport.com/device/K253253
Methodology: https://510kreport.com/methodology