Cleared Traditional

K993717 - ENIGMA HI-BASE DENTURE BASE MATERIAL

K993717 is an FDA 510(k) clearance for ENIGMA HI-BASE DENTURE BASE MATERIAL, 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 49-day FDA review.

K993717 · Davis Schottlander & Davis, Ltd. · Dental device
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Dec 1999
Decision
49d
Days
Class 2
Risk

K993717 is an FDA 510(k) clearance for the ENIGMA HI-BASE DENTURE BASE MATERIAL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Davis Schottlander & Davis, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on December 22, 1999 after a review of 49 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 - K993717

510(k) Number K993717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1999
Decision Date December 22, 1999
Days to Decision 49 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
79d faster than avg
Panel avg: 128d · This submission: 49d
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 K993717.
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
K001463 · Davis Schottlander & Davis, Ltd. · 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
MODIFICATION TO LINER II: SOFT RELINE LIQUID
K991687 · Bosworth Co. · Oct 1999
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · Dentsply Intl. · Oct 1999
NIC TONE ACRYLIC RESINS
K991577 · Manufacturera Dental Continental · Sep 1999
K993717 · ENIGMA HI-BASE DENTURE BASE MATERIAL
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