Cleared Traditional

K883211 - IMZ O-RING ATTACHMENT

K883211 is an FDA 510(k) clearance for IMZ O-RING ATTACHMENT, manufactured by Interpore Intl.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K883211 · Interpore Intl. · Dental device
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Nov 1988
Decision
111d
Days
Class 2
Risk

K883211 is an FDA 510(k) clearance for the IMZ O-RING ATTACHMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Interpore Intl. (Irvine, US). The FDA issued a Cleared decision on November 17, 1988 after a review of 111 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 Interpore Intl. devices

FDA 510(k) Submission Details - K883211

510(k) Number K883211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1988
Decision Date November 17, 1988
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
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 699
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K883211.
BONEFIT HOLLOW CYLINDER IMPLANTS
K894593 · Institut Straumann AG · Feb 1990
BONEFIT HOLLOW SCREW IMPLANTS
K894594 · Institut Straumann AG · Feb 1990
BONEFIT R SCREW IMPLANTS
K894595 · Institut Straumann AG · Feb 1990
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
K871219 · Depuy, Inc. · Jun 1987
MONOJECT ENDOSSEOUS DENTAL IMPLANT
K781060 · Sherwood Medical Industries · Aug 1978