Cleared Traditional

K862177 - IDEX DENTAL IMPLANT

K862177 is an FDA 510(k) clearance for IDEX DENTAL IMPLANT, manufactured by R. J. Chapman, D.M.D.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K862177 · R. J. Chapman, D.M.D. · Dental device
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Dec 1986
Decision
176d
Days
Class 2
Risk

K862177 is an FDA 510(k) clearance for the IDEX DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by R. J. Chapman, D.M.D. (Brookline, US). The FDA issued a Cleared decision on December 2, 1986 after a review of 176 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 R. J. Chapman, D.M.D. devices

FDA 510(k) Submission Details - K862177

510(k) Number K862177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1986
Decision Date December 02, 1986
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 128d · This submission: 176d
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 1331
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K862177.
ADBUTMENT CYLINDER AND SCREW
K871863 · Implant Innovations International, Inc. · Jul 1987
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
K871219 · Depuy, Inc. · Jun 1987
MICRO-VENT
K864321 · Core-Vent Corp. · Jan 1987
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT
K861425 · Core-Vent Corp. · Nov 1986
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K863680 · Interpore Intl. · Oct 1986
SCREW-VENT (TM) IMPLANT/ENDOSSEOUS SCREW IMPLANT
K861426 · Core-Vent Corp. · Oct 1986