Cleared Traditional

TENDER ORTHO BOND-ENA BOND-ENA ETCH (K072978) - FDA 510(k) Clearance

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

K072978 · Micerium S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
87d
Days
Class 2
Risk

K072978 is an FDA 510(k) clearance for the TENDER ORTHO BOND-ENA BOND-ENA ETCH. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Micerium S.P.A. (Avegno, Genoa, IT). The FDA issued a Cleared decision on January 17, 2008 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 Micerium S.P.A. devices

Submission Details

510(k) Number K072978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2007
Decision Date January 17, 2008
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 192
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