Cleared Traditional

Inclusive? Titanium Abutments compatible with: Camlog? CONELOG? Implant System, Dentium? NR Line Implant Systems

K252582 · Prismatik Dentalcraft, Inc. · Dental

Nov 2025

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K252582 is an FDA 510(k) clearance for the Inclusive? Titanium Abutments compatible with: Camlog? CONELOG? Implant System, Dentium? NR Line Implant Systems, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on November 18, 2025, 95 days after receiving the submission on August 15, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K252582 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2025
Decision Date	November 18, 2025
Days to Decision	95 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.