Cleared Traditional

K052733 - ALMITECH INC. DENTAL IMPLANT SYSTEM

K052733 is an FDA 510(k) clearance for ALMITECH INC. DENTAL IMPLANT SYSTEM, manufactured by Almitech, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K052733 · Almitech, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
84d
Days
Class 2
Risk

K052733 is an FDA 510(k) clearance for the ALMITECH INC. DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Almitech, Inc. (Bellmore, US). The FDA issued a Cleared decision on December 22, 2005 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 - K052733

510(k) Number K052733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date December 22, 2005
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1529
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K052733.
EXFEEL IMPLANT SYSTEM
K052369 · Megagen Co., Ltd. · Jan 2006
PITT-EASY DENTAL IMPLANT SYSTEM
K053242 · Innova Life Sciences Corp. · Jan 2006
HDC SPIDER SCREW
K052471 · Hdc S.R.L. · Dec 2005
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K052490 · Northern Implants, LLC · Dec 2005
BIOHORIZONS SINGLE-STAGE IMPLANT
K053152 · BioHorizons Implant Systems, Inc. · Dec 2005
MODUS IMF SCREWS 2.0
K052061 · Medartis, Inc. · Oct 2005
K052733 · ALMITECH INC. DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Almitech, Inc.