Cleared Traditional

K964691 - TCB TEMPORARY CROWN AND BRIDGE MATERIAL

K964691 is an FDA 510(k) clearance for TCB TEMPORARY CROWN AND BRIDGE MATERIAL, manufactured by Scican. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K964691 · Scican · Dental device
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Feb 1997
Decision
74d
Days
Class 2
Risk

K964691 is an FDA 510(k) clearance for the TCB TEMPORARY CROWN AND BRIDGE MATERIAL. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Scican (Toronto, CA). The FDA issued a Cleared decision on February 4, 1997 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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.

View all Scican devices

FDA 510(k) Submission Details - K964691

510(k) Number K964691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date February 04, 1997
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 130
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K964691.
DENT-TEMP ACRYLIC
K972198 · Health-Dent Intl., Inc. · Dec 1997
3M QUIKPLUS SYSTEM
K970168 · 3M Company · Feb 1997
TEMPFIL C&B
K964981 · Sybron Dental Specialties, Inc. · Feb 1997
TEMPFIL F
K963786 · Sybron Dental Specialties, Inc. · Nov 1996
BOSWORTH TEMPORARY RESIN
K961199 · Harry J. Bosworth Co. · Jun 1996
BOSWORTH CH I
K961198 · Harry J. Bosworth Co. · May 1996