Cleared Traditional

K262207 - Cemented Plus Abutment

K262207 is an FDA 510(k) clearance for Cemented Plus Abutment, manufactured by Unidental Co., Ltd.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K262207 · Unidental Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
85d
Days
Class 2
Risk

K262207 is an FDA 510(k) clearance for the Cemented Plus Abutment. 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 Unidental Co., Ltd. (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on September 23, 2026 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Unidental Co., Ltd. devices

FDA 510(k) Submission Details - K262207

510(k) Number K262207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2026
Decision Date September 23, 2026
Days to Decision 85 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
43d faster than avg
Panel avg: 128d · This submission: 85d
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 K262207.
Elos Accurate Hybrid Base
K261327 · Elos Medtech Pinol A/S · Sep 2026
BellaTek Bars
K260940 · ZimVie US Corp, LLC · Sep 2026
Universal Base ASC Engaging
K253999 · Nobel Biocare AB · Aug 2026
Neodent Implant System - NeoConvert Fit
K261147 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Jul 2026
MIST IC
K261122 · Imagine Milling Technologies, LLC · Jun 2026
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)
K260061 · BioHorizons Implant Systems, Inc. · Jun 2026