Cleared Traditional

ULTRACAPS S (K081273) - FDA 510(k) Clearance

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

K081273 · Sdi , Ltd. · Dental device
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Jul 2008
Decision
66d
Days
Class 2
Risk

K081273 is an FDA 510(k) clearance for the ULTRACAPS S. Classified as Dental Amalgam (product code OIV), Class II - Special Controls.

Submitted by Sdi , Ltd. (Bayswater, Victoria, AU). The FDA issued a Cleared decision on July 10, 2008 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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.

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Submission Details

510(k) Number K081273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date July 10, 2008
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OIV Dental Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
Definition Dental Amalgam Is A Device That Consists Of A Metallic Alloy, Such As Silver, Tin, Copper, And Zinc, That Is Mixed With Liquid Elemental Mercury For The Direct Filling Of Carious Lesions Or Structural Defects In Teeth
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.