Cleared Traditional

K001463 - SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

K001463 is an FDA 510(k) clearance for SCHOTTLANDER ENIGMA COLOUR TONE, manufactured by Davis Schottlander & Davis, Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K001463 · Davis Schottlander & Davis, Ltd. · Dental device
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Jun 2000
Decision
37d
Days
Class 2
Risk

K001463 is an FDA 510(k) clearance for the SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Davis Schottlander & Davis, Ltd. (Kansas City, US). The FDA issued a Cleared decision on June 16, 2000 after a review of 37 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 - K001463

510(k) Number K001463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date June 16, 2000
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 128d · This submission: 37d
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 320
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K001463.
STICK
K003333 · Stick Tech , Ltd. · Jan 2001
JBC OPAQUE AND GLITTER
K002048 · J.B.C and Co. · Aug 2000
BIOSOFT RESIN
K001640 · Biosoft International Corp. · Jun 2000
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
K992176 · St. George Technology, Inc. · Feb 2000
UFI GEL HARD
K993827 · Voco GmbH · Jan 2000
ENIGMA HI-BASE DENTURE BASE MATERIAL
K993717 · Davis Schottlander & Davis, Ltd. · Dec 1999
K001463 · SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
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