Cleared Traditional

K911669 - CERAPALL 6

K911669 is an FDA 510(k) clearance for CERAPALL 6, manufactured by Metalor Dental USA Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K911669

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.

EJS Device Classification - Class 2, Special Controls

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 171
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