Cleared Traditional

K905436 - NOBELPHARMA DRILLING EQUIPMENT DEC 500

K905436 is the FDA 510(k) clearance for NOBELPHARMA DRILLING EQUIPMENT DEC 500 by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905436 · Nobelpharma USA, Inc. · Dental device
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Mar 1991
Decision
90d
Days
Class 2
Risk

K905436 is an FDA 510(k) clearance for the NOBELPHARMA DRILLING EQUIPMENT DEC 500. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Chicago, US). The FDA issued a Cleared decision on March 4, 1991 after a review of 90 days - within the typical 510(k) review window.

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 Nobelpharma USA, Inc. devices

Submission Details

510(k) Number K905436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date March 04, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 674
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K905436.
BC 1211 ABUTMENT, FIXED TRANSFER PIN, INDIRECT
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K904703 · Minimatic Implant Technology · 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
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K903113 · Minimatic Implant Technology · Dec 1990