Cleared Traditional

K000889 - SENOJ IMPLANT SYSTEM

K000889 is an FDA 510(k) clearance for SENOJ IMPLANT SYSTEM, manufactured by Senoj Biocare, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K000889 · Senoj Biocare, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
403d
Days
Class 2
Risk

K000889 is an FDA 510(k) clearance for the SENOJ IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Senoj Biocare, Inc. (San Diego, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 403 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.

FDA 510(k) Submission Details - K000889

510(k) Number K000889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date April 27, 2001
Days to Decision 403 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 128d · This submission: 403d
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 1546
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K000889.
TAPER-LOCK DENTAL IMPLANT SYSTEM
K011038 · Sulzer Dental, Inc. · May 2001
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
DUO-DENT DENTAL IMPLANT
K010386 · Duo-Dent Dental Implant Systems, LLC · Feb 2001
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316
K010343 · Buck Medical Research · Feb 2001
K000889 · SENOJ IMPLANT SYSTEM
Download PDF FDA Summary Senoj Biocare, Inc.