Cleared Traditional

K820013 - TITANIUM IMPLANT DEVICES

K820013 is an FDA 510(k) clearance for TITANIUM IMPLANT DEVICES, manufactured by Bofors Nobelpharma, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K820013 · Bofors Nobelpharma, Inc. · Dental device
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Mar 1982
Decision
55d
Days
Class 2
Risk

K820013 is an FDA 510(k) clearance for the TITANIUM IMPLANT DEVICES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bofors Nobelpharma, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bofors Nobelpharma, Inc. devices

FDA 510(k) Submission Details - K820013

510(k) Number K820013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1982
Decision Date March 01, 1982
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
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.