Cleared Traditional

Klockner Abutments (K230103) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230103 · SOADCO, S.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
101d
Days
Class 2
Risk

K230103 is an FDA 510(k) clearance for the Klockner Abutments. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by SOADCO, S.L. (Escaldes - Engordany, AD). The FDA issued a Cleared decision on April 24, 2023 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all SOADCO, S.L. devices

Submission Details

510(k) Number K230103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2023
Decision Date April 24, 2023
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K230103.
Customized Abutment
K223634 · Arum Dentistry Co., Ltd. · Apr 2023
Titanium Abutment Blank Nobel Biocare N1 TCC
K223677 · Nobel Biocare AB · Apr 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
K230218 · Dental Direkt GmbH · Apr 2023
TIB Abutments
K222469 · Southern Implants (Pty), Ltd. · Apr 2023
DESS Dental Smart Solutions
K230143 · Terrats Medical SL · Apr 2023
S.I.N. Dental Implant System
K230069 · S.I.N. ? Sistema DE Implante Nacional S.A. · Apr 2023