Cleared Traditional

IPD Dental Implant Abutments

K231413 · Implant Protesis Dental 2004, S.L. · Dental

Oct 2023

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K231413 is an FDA 510(k) clearance for the IPD Dental Implant Abutments, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Implant Protesis Dental 2004, S.L. (Mataro, ES). The FDA issued a Cleared decision on October 10, 2023, 147 days after receiving the submission on May 16, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K231413 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2023
Decision Date	October 10, 2023
Days to Decision	147 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.