Cleared Traditional

K903999 - OBUTMENT HB

K903999 is an FDA 510(k) clearance for OBUTMENT HB, 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 531-day FDA review.

K903999 · "O" Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
531d
Days
Class 2
Risk

K903999 is an FDA 510(k) clearance for the OBUTMENT HB. 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 February 11, 1992 after a review of 531 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all "O" Co., Inc. devices

FDA 510(k) Submission Details - K903999

510(k) Number K903999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date February 11, 1992
Days to Decision 531 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
404d slower than avg
Panel avg: 127d · This submission: 531d
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 K903999.
ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102
K905434 · Nobelpharma USA, Inc. · Aug 1992
STERI-OSS DRILLS AND TAPS
K915733 · Steri-Oss, Inc. · Jul 1992
IMZ SURGICAL INSTRUMENT TRAY
K921246 · Interpore Intl. · Jun 1992
PRE-ANGLED ABUTMENTS
K912059 · Core-Vent Corp. · Feb 1992
BUR,DENTAL (76EJL)
K915597 · Calcitek, Inc. · Feb 1992
DPI-1106 IMPLANT, MODIFICATION
K911776 · Minimatic Implant Technology · Jan 1992