Cleared Traditional

K142130 - ORAL BOND

K142130 is an FDA 510(k) clearance for ORAL BOND, manufactured by Steiner Laboratories. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 672-day FDA review.

K142130 · Steiner Laboratories · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
672d
Days
Class 2
Risk

K142130 is an FDA 510(k) clearance for the ORAL BOND. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Steiner Laboratories (Henderson, US). The FDA issued a Cleared decision on June 6, 2016 after a review of 672 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

FDA 510(k) Submission Details - K142130

510(k) Number K142130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2014
Decision Date June 06, 2016
Days to Decision 672 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
544d slower than avg
Panel avg: 128d · This submission: 672d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 460
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