Cleared Traditional

K900545 - O-RING PROSTHETIC ATTACHMENT DEVICE

K900545 is the FDA 510(k) clearance for O-RING PROSTHETIC ATTACHMENT DEVICE by Calcitek, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K900545 · Calcitek, Inc. · Dental device
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Jun 1990
Decision
137d
Days
Class 2
Risk

K900545 is an FDA 510(k) clearance for the O-RING PROSTHETIC ATTACHMENT DEVICE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Calcitek, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 137 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 Calcitek, Inc. devices

Submission Details

510(k) Number K900545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1990
Decision Date June 22, 1990
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 127d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 676
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K900545.
DG-1109 DEPTH GAGE
K903115 · Minimatic Implant Technology · Nov 1990
BO-1121 BALL OVERDENTURE ATTACHMENT
K903516 · Minimatic Implant Technology · Nov 1990
AIB-1120 ANALOG-IMPLANT BODY
K903517 · Minimatic Implant Technology · Nov 1990
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