Cleared Traditional

Elos Accurate® Hybrid Base™ (K241722) - FDA 510(k) Clearance

Also marketed or referenced as:
Elos Accurate® Customized Abutment

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

K241722 · Elos Medtech Pinol A/S · Dental device
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Sep 2024
Decision
91d
Days
Class 2
Risk

K241722 is an FDA 510(k) clearance for the Elos Accurate® Hybrid Base™. 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 Elos Medtech Pinol A/S (Goerloese, DK). The FDA issued a Cleared decision on September 13, 2024 after a review of 91 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 Elos Medtech Pinol A/S devices

Submission Details

510(k) Number K241722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2024
Decision Date September 13, 2024
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
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 K241722.
PreXolid CAD/CAM abutments
K240725 · Eclectic Co., Ltd. · Oct 2024
TruAbutment DS
K241485 · Truabutment, Inc. · Oct 2024
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
K234142 · Megagen Implant Co., Ltd. · Sep 2024
DESS Dental Smart Solutions
K240982 · Terrats Medical SL · Aug 2024
TDS (TECHWIN DENTAL SYSTEM)
K231932 · Techwin Co., Ltd. · Aug 2024
SmartShape™ Healing Abutment
K240531 · BioHorizons Implant Systems, Inc. · Jul 2024