Cleared Traditional

K001269 - DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC

K001269 is an FDA 510(k) clearance for DENTALMATIC TI PROSTHESIS AND DENTALMAT..., manufactured by Dentalmatic Technologies, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K001269 · Dentalmatic Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
62d
Days
Class 2
Risk

K001269 is an FDA 510(k) clearance for the DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Dentalmatic Technologies, Inc. (St Laurent, Qc, CA). The FDA issued a Cleared decision on June 21, 2000 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001269

510(k) Number K001269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2000
Decision Date June 21, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
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 152
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K001269.
SUPER 1
K002298 · Dental Alloy Products, Inc. · Aug 2000
DC TITAN
K001798 · Austenal, Inc. · Jul 2000
SUPREMCAST V
K001383 · American Dent-All, Inc. · Jul 2000
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
K000981 · C-Mix · Jun 2000
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
K993572 · Matech, Inc. · Dec 1999
HI BOND NON-PRECIOUS CERAMIC ALLOY
K992881 · Matech, Inc. · Nov 1999
K001269 · DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
Download PDF FDA Summary Dentalmatic Technolog…