Cleared Traditional

K903211 - O BUTMENT

K903211 is an FDA 510(k) clearance for O BUTMENT, manufactured by "O" Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K903211 · "O" Co., Inc. · Dental device
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Mar 1991
Decision
252d
Days
Class 2
Risk

K903211 is an FDA 510(k) clearance for the O BUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by "O" Co., Inc. (Albuquerque, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 252 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 "O" Co., Inc. devices

FDA 510(k) Submission Details - K903211

510(k) Number K903211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1990
Decision Date March 29, 1991
Days to Decision 252 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 127d · This submission: 252d
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 868
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K903211.
ICT-1108 IMPLANT- THREADED (CEMENT TYPE ABUTMENT)
K903043 · Minimatic Implant Technology · Apr 1991
IDT-1104 IMPLANT (SCREW-IN-THREADED)
K903046 · Minimatic Implant Technology · Apr 1991
BC 1206 IMPLANT - INSERT TYPE
K904705 · Minimatic Implant Technology · Apr 1991
BC 1219 HEALING HEAD
K904710 · Minimatic Implant Technology · Mar 1991
BC 1221 BALL OVERDENTURE ATTACHMENT
K904712 · Minimatic Implant Technology · Mar 1991
BC 1203 ABUTMENT TAPERED SHOULDER
K904704 · Minimatic Implant Technology · Mar 1991