Cleared Traditional

K102984 - AURA

K102984 is an FDA 510(k) clearance for AURA, manufactured by Sdi Limited. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K102984 · Sdi Limited · Dental device
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Dec 2010
Decision
62d
Days
Class 2
Risk

K102984 is an FDA 510(k) clearance for the AURA. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on December 8, 2010 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Sdi Limited devices

FDA 510(k) Submission Details - K102984

510(k) Number K102984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2010
Decision Date December 08, 2010
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 836
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