Cleared Traditional

K911669 - CERAPALL 6

K911669 is the FDA 510(k) clearance for CERAPALL 6 by Metalor Dental USA Corp.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K911669 · Metalor Dental USA Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
127d
Days
Class 2
Risk

K911669 is an FDA 510(k) clearance for the CERAPALL 6. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Metalor Dental USA Corp. devices

Submission Details

510(k) Number K911669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date August 16, 1991
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 117
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K911669.
X-L (DW228-14A) AND X-LX (DW228-24A)
K913070 · Ivoclar North America, Inc. · Sep 1991
ULTRACROWN(TM) PD DENTAL ALLOY
K913232 · Dentsply Intl. · Sep 1991
DEGUBOND LITE
K912493 · Degussa AG · Aug 1991
CERAPLUS
K911674 · Metalor Dental USA Corp. · Aug 1991
VACU 2
K912302 · Metalor Dental USA Corp. · Aug 1991
STANDARD S3
K912305 · Metalor Dental USA Corp. · Aug 1991