Cleared Abbreviated

K082249 - MORPHEUS

K082249 is an FDA 510(k) clearance for MORPHEUS, manufactured by Meibach Tech Ltda. The device is a Class 2 Dental device with product code EJI cleared through the Abbreviated 510(k) pathway after a 510-day FDA review.

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.

FDA 510(k) Submission Details - K082249

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
382d slower than avg
Panel avg: 128d · This submission: 510d
Pathway characteristics
Standards-based clearance path.

EJI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EJI Syringe, Cartridge

All 36
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K082249.
Miltex N-Tralig Intraligamentary Syringe
K142414 · Integra LifeSciences Corporation · Oct 2014
HU-FRIEDY DENTAL CARTRIDGE SYRINGE
K120659 · Hu-Friedy Mfg. Co., LLC · Nov 2012
ANESTHESIA INJECTION TOOL SET
K113247 · Ki Works Co., Ltd. · Mar 2012
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
K092943 · Arnold Tuber Industries · Dec 2009
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
K083796 · Miltex, Inc. · Mar 2009
DENJECTOR
K081694 · Dxm Co., Ltd. · Sep 2008
K082249 · MORPHEUS
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