Cleared Traditional

K050970 - MILO DENTAL IMPLANT SYSTEM

K050970 is an FDA 510(k) clearance for MILO DENTAL IMPLANT SYSTEM, manufactured by Intra-Lock International. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K050970 · Intra-Lock International · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
179d
Days
Class 2
Risk

K050970 is an FDA 510(k) clearance for the MILO DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Intra-Lock International (Boca Raton, US). The FDA issued a Cleared decision on October 14, 2005 after a review of 179 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.

FDA 510(k) Submission Details - K050970

510(k) Number K050970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date October 14, 2005
Days to Decision 179 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
51d slower than avg
Panel avg: 128d · This submission: 179d
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 1450
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K050970.
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
SISTEMA DE IMPLANTE NACIONAL (S.I.N.)
K051859 · Sin Sistema DE Implante Nacional Ltda · Sep 2005
MAXIMUS 3.0 AND OS IMPLANTS
K052419 · BioHorizons Implant Systems, Inc. · Sep 2005
O.A.S.I. SYSTEM
K051552 · Lancer Orthodontics, Inc. · Sep 2005
K050970 · MILO DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Intra-Lock Internatio…