Cleared Traditional

K261327 - Elos Accurate Hybrid Base

K261327 is an FDA 510(k) clearance for Elos Accurate Hybrid Base, manufactured by Elos Medtech Pinol A/S. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K261327 · Elos Medtech Pinol A/S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
161d
Days
Class 2
Risk

K261327 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 30, 2026 after a review of 161 days - an extended review cycle.

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

FDA 510(k) Submission Details - K261327

510(k) Number K261327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2026
Decision Date September 30, 2026
Days to Decision 161 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
33d slower than avg
Panel avg: 128d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

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 712
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K261327.
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