Cleared Traditional

K083876 - SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4...

K083876 is the FDA 510(k) clearance for SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4... by Cendres & Metaux SA. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 424-day FDA review.

K083876 · Cendres & Metaux SA · Dental device
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Feb 2010
Decision
424d
Days
Class 2
Risk

K083876 is an FDA 510(k) clearance for the SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT. 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 Cendres & Metaux SA (Biel/Bienne, CH). The FDA issued a Cleared decision on February 26, 2010 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Cendres & Metaux SA devices

Submission Details

510(k) Number K083876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date February 26, 2010
Days to Decision 424 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 127d · This submission: 424d
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 464
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