Cleared Traditional

K961861 - VARIOUS DENTAL IMPLANTS WITH COVER SCREWS

K961861 is an FDA 510(k) clearance for VARIOUS DENTAL IMPLANTS WITH COVER SCREWS, manufactured by Implant Management of America. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K961861 · Implant Management of America · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
100d
Days
Class 2
Risk

K961861 is an FDA 510(k) clearance for the VARIOUS DENTAL IMPLANTS WITH COVER SCREWS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Management of America (Miami, US). The FDA issued a Cleared decision on August 22, 1996 after a review of 100 days - within the typical 510(k) review window.

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 Implant Management of America devices

FDA 510(k) Submission Details - K961861

510(k) Number K961861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date August 22, 1996
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
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 984
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K961861.
NOBLEPHARMA WIDE ACCESSORIES
K962403 · Nobelpharma USA, Inc. · Sep 1996
OSTEO COMPACTION KIT
K962449 · Steri-Oss, Inc. · Sep 1996
SPLINE DENTAL IMPLANT SYSTEMS
K962106 · Calcitek, Inc. · Aug 1996
PLASTIC PROTECTION HEALING CAPS
K962023 · The Straumann Co. · Aug 1996
STERI-OSS APICAL IMPLANT
K960398 · Steri-Oss, Inc. · Aug 1996
3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS
K960417 · Implant Innovations, Inc. · Aug 1996