Cleared Traditional

K972351 - SENDAX MDI (MINI DENTAL IMPLANT)

K972351 is an FDA 510(k) clearance for SENDAX MDI (MINI DENTAL IMPLANT), manufactured by Sendax Mdic Management, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K972351 · Sendax Mdic Management, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
153d
Days
Class 2
Risk

K972351 is an FDA 510(k) clearance for the SENDAX MDI (MINI DENTAL IMPLANT). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sendax Mdic Management, Inc. (New York, US). The FDA issued a Cleared decision on November 24, 1997 after a review of 153 days - an extended review 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: 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 Sendax Mdic Management, Inc. devices

FDA 510(k) Submission Details - K972351

510(k) Number K972351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1997
Decision Date November 24, 1997
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
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 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K972351.
DENTAL/SURGICAL DRILLS, BURS, TAPS
K973771 · Implant Innovations, Inc. · Dec 1997
BONDING BASE
K973353 · Straumann USA · Dec 1997
STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM
K973402 · Steri-Oss, Inc. · Nov 1997
VARIABLE PARALLEL PIN
K973521 · Sulzer Calcitek, Inc. · Nov 1997
OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4
K972769 · Opti-Max · Nov 1997
IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM
K973049 · Imcor · Nov 1997