Cleared Traditional

K011200 - GILB, MODEL 8010

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

K011200 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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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FDA 510(k) Submission Details - K011200

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.

EMA Device Classification - Class 2, Special Controls

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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K011200.
PERMACEM / PERMACEM DUAL
K012316 · Dmg USA, Inc. · Aug 2001
PREVISION CHEM
K010541 · Heraeus Kulzer, Inc. · Jul 2001
BISTITE II DC
K011685 · Tokuyama America, Inc. · Jul 2001
RESIN CEM
K011431 · S & C Polymer GmbH · Jun 2001
ONE-STEP PLUS
K011159 · Bisco, Inc. · Jun 2001
CLASSIC CEM
K011064 · S & C Polymer GmbH · May 2001