Cleared Traditional

IPDmilled Blanks

K253253 · Implant Protesis Dental 2004, S.L. · Dental

Jan 2026

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K253253 is an FDA 510(k) clearance for the IPDmilled Blanks, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Implant Protesis Dental 2004, S.L. (Premi? De Dalt (Barcelona), ES). The FDA issued a Cleared decision on January 22, 2026, 115 days after receiving the submission on September 29, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K253253 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	January 22, 2026
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.