Cleared Traditional

K040881 - METACRYL

K040881 is an FDA 510(k) clearance for METACRYL, manufactured by Great Lakes Orthodontics, Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K040881 · Great Lakes Orthodontics, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
50d
Days
Class 2
Risk

K040881 is an FDA 510(k) clearance for the METACRYL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Great Lakes Orthodontics, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on May 25, 2004 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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.

FDA 510(k) Submission Details - K040881

510(k) Number K040881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date May 25, 2004
Days to Decision 50 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
78d faster than avg
Panel avg: 128d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 303
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K040881.
PALAIMPACT
K043504 · Heraeus Kulzer, Inc. · Jan 2005
VERSYO.DIRECT
K043295 · Heraeus Kulzer, Inc. · Jan 2005
TUF LINK SILICONE RELINER
K042931 · Dentatus USA , Ltd. · Dec 2004
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
K034024 · Bisco, Inc. · Mar 2004
VARIFLEX
K033632 · Great Lakes Orthodontics, Ltd. · Jan 2004
TESCERA U-BAR AND BARRELS
K033472 · Bisco, Inc. · Jan 2004
K040881 · METACRYL
Download PDF FDA Summary Great Lakes Orthodont…