Cleared Traditional

K900694 - CASTABLE ABUTMENTS

K900694 is the FDA 510(k) clearance for CASTABLE ABUTMENTS by Calcitek, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K900694 · Calcitek, Inc. · Dental device
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Feb 1991
Decision
363d
Days
Class 2
Risk

K900694 is an FDA 510(k) clearance for the CASTABLE ABUTMENTS. 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 February 11, 1991 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K900694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date February 11, 1991
Days to Decision 363 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 127d · This submission: 363d
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 K900694.
BC 1213 HEALING SCREW
K904709 · Minimatic Implant Technology · Mar 1991
BC-1201 CAST ABUTMENT
K904703 · Minimatic Implant Technology · Mar 1991
NOBELPHARMA DRILLING EQUIPMENT DEC 500
K905436 · Nobelpharma USA, Inc. · Mar 1991
DEVICE PART NUMBER DPI-1106 IMPLANT
K902928 · Minimatic Implant Technology · Jan 1991
BC 1220 ANALOG - IMPLANT BODY
K904711 · Minimatic Implant Technology · Jan 1991
CGA-112 COPING GOLD ALLOY
K903113 · Minimatic Implant Technology · Dec 1990