Cleared Abbreviated

MORPHEUS (K082249) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K082249 · Meibach Tech Ltda · Dental device
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Dec 2009
Decision
510d
Days
Class 2
Risk

K082249 is an FDA 510(k) clearance for the MORPHEUS. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Meibach Tech Ltda (New York, US). The FDA issued a Cleared decision on December 31, 2009 after a review of 510 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 Meibach Tech Ltda devices

Submission Details

510(k) Number K082249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2008
Decision Date December 31, 2009
Days to Decision 510 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
383d slower than avg
Panel avg: 127d · This submission: 510d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
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.