Cleared Traditional

K060530 - SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.

K060530 is an FDA 510(k) clearance for SD CERAMIC COPING FOR QUICK ABUTMENT, manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K060530 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
83d
Days
Class 2
Risk

K060530 is an FDA 510(k) clearance for the SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPIN.... Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on May 22, 2006 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Lifecore Biomedical, Inc. devices

FDA 510(k) Submission Details - K060530

510(k) Number K060530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2006
Decision Date May 22, 2006
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 30
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K060530.
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