Cleared Traditional

K062493 - LAVA SOFTWARE

K062493 is an FDA 510(k) clearance for LAVA SOFTWARE, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K062493 · 3M Espe AG Dental Products · Dental device
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Nov 2006
Decision
84d
Days
Class 2
Risk

K062493 is an FDA 510(k) clearance for the LAVA SOFTWARE. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on November 17, 2006 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K062493

510(k) Number K062493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2006
Decision Date November 17, 2006
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 533
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