Cleared Traditional

K910569 - TYCERAMIC

K910569 is an FDA 510(k) clearance for TYCERAMIC, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K910569 · Jeneric/Pentron, Inc. · Dental device
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Apr 1991
Decision
63d
Days
Class 2
Risk

K910569 is an FDA 510(k) clearance for the TYCERAMIC. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on April 15, 1991 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K910569

510(k) Number K910569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1991
Decision Date April 15, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 27
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K910569.
DUCERAGOLD, DUCERATIN
K931808 · Degussa AG · Nov 1993
IPS CERAMIC ETCHING GEL
K923926 · Ivoclar North America, Inc. · Oct 1992
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
K920460 · Pulpdent Corp. · Apr 1992
SYSNPAR PORCELAIN
K910303 · Jeneric/Pentron, Inc. · Mar 1991
PROCERAM PORCELAIN
K903907 · Nobelpharma USA, Inc. · Nov 1990
DEN-MAT LAMI-QUICK
K895269 · Den-Mat Corp. · Feb 1990