Cleared Traditional

K011200 - GILB

K011200 is the FDA 510(k) clearance for GILB by 3M Company. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K011200 · 3M Company · Dental device
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Jun 2001
Decision
56d
Days
Class 2
Risk

K011200 is an FDA 510(k) clearance for the GILB, MODEL 8010. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Company (St Paul, US). The FDA issued a Cleared decision on June 14, 2001 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

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Submission Details

510(k) Number K011200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date June 14, 2001
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K011200.
PANAVIA F
K012441 · Kuraray Medical, Inc. · Sep 2001
MODIFICATION TO PANAVIA 21
K012438 · Kuraray Medical, Inc. · Sep 2001
PREVISION CHEM
K010541 · Heraeus Kulzer, Inc. · Jul 2001
ONE-STEP PLUS
K011159 · Bisco, Inc. · Jun 2001
SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)
K003407 · Ivoclar North America, Inc. · Jan 2001
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001