Cleared Traditional

K000035 - OMNICARE DENTAL IMPLANT SYSTEM

K000035 is an FDA 510(k) clearance for OMNICARE DENTAL IMPLANT SYSTEM, manufactured by Omnicare Dental Implant Center. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 631-day FDA review.

K000035 · Omnicare Dental Implant Center · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
631d
Days
Class 2
Risk

K000035 is an FDA 510(k) clearance for the OMNICARE DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Omnicare Dental Implant Center (San Diego, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 631 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 - K000035

510(k) Number K000035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2000
Decision Date September 28, 2001
Days to Decision 631 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
503d slower than avg
Panel avg: 128d · This submission: 631d
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 K000035.
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K003191 · Mis Implants Technologies , Ltd. · Sep 2001
UNIVERSAL DENTAL COPING (UDC)
K010467 · Paxmed International · Sep 2001
UCLA AND UNIVERSAL ABUTMENTS
K010619 · Diamodent · Sep 2001
K000035 · OMNICARE DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Omnicare Dental Impla…