Cleared Traditional

S.I.N. Dental Implant System (K252266) - FDA 510(k) Clearance

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

K252266 · S.I.N. Implant System Ltda · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
88d
Days
Class 2
Risk

K252266 is an FDA 510(k) clearance for the S.I.N. Dental Implant System. 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 S.I.N. Implant System Ltda (São Paulo, BR). The FDA issued a Cleared decision on October 17, 2025 after a review of 88 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 S.I.N. Implant System Ltda devices

Submission Details

510(k) Number K252266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2025
Decision Date October 17, 2025
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 K252266.
DESS Dental Smart Solutions
K251547 · Terrats Medical SL · Oct 2025
DESS® Dental Smart Solutions
K252384 · Terrats Medical SL · Oct 2025
Adin Customized Abutments
K250178 · Adin Dental Implant Systems , Ltd. · Oct 2025
Elos Accurate Hybrid Base
K251497 · Elos Medtech Pinol A/S · Oct 2025
Bonafix Implant Abutments
K251294 · Zentek Medical, LLC · Oct 2025
LOCATOR® Angled Abutment
K252944 · Zest Anchors, LLC · Oct 2025