Cleared Traditional

K973513 - SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER

K973513 is an FDA 510(k) clearance for SINFONY DENTIN, manufactured by Espe GmbH & Co. Kg.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K973513 · Espe GmbH & Co. Kg. · Dental device
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Optimized for regulatory review, auditing and printing
Dec 1997
Decision
96d
Days
Class 2
Risk

K973513 is an FDA 510(k) clearance for the SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINF.... Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe GmbH & Co. Kg. (Seefeld, DE). The FDA issued a Cleared decision on December 22, 1997 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Espe GmbH & Co. Kg. devices

FDA 510(k) Submission Details - K973513

510(k) Number K973513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1997
Decision Date December 22, 1997
Days to Decision 96 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
31d faster than avg
Panel avg: 127d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 708
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K973513.
COMPOGLASS FLOW
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VITALESCENCE
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KERR COMPOMER
K974105 · Sybron Dental Specialties, Inc. · Jan 1998
ALERT
K974131 · Jeneric/Pentron, Inc. · Dec 1997
FREEDOM
K973089 · Southern Dental Industries, Inc. · Dec 1997
WAVE
K973091 · Southern Dental Industries, Inc. · Dec 1997