Cleared Traditional

K926165 - CERAMCO CROWNS AND BRIDGES

K926165 is an FDA 510(k) clearance for CERAMCO CROWNS AND BRIDGES, manufactured by Asap Dental Lab, Ltd.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 478-day FDA review.

K926165 · Asap Dental Lab, Ltd. · Dental device
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Mar 1994
Decision
478d
Days
Class 2
Risk

K926165 is an FDA 510(k) clearance for the CERAMCO CROWNS AND BRIDGES. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Asap Dental Lab, Ltd. (Newburgh, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Asap Dental Lab, Ltd. devices

FDA 510(k) Submission Details - K926165

510(k) Number K926165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date March 31, 1994
Days to Decision 478 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
351d slower than avg
Panel avg: 127d · This submission: 478d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 100
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K926165.
VERABOND V
K945712 · Aalba Dent, Inc. · Dec 1994
VERABOND II
K945713 · Aalba Dent, Inc. · Dec 1994
VERABOND III
K945714 · Aalba Dent, Inc. · Dec 1994
VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
K932893 · Vident · Mar 1994
LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10
K940749 · Aalba Dent, Inc. · Mar 1994
R2+
K934758 · Jeneric/Pentron, Inc. · Feb 1994