Cleared Traditional

GENERATION 5 LINKOW BLADE IMPLANTS (K822969) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822969 · Leonard P. Linkow, D.D.L. · Dental device
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Nov 1982
Decision
27d
Days
Class 2
Risk

K822969 is an FDA 510(k) clearance for the GENERATION 5 LINKOW BLADE IMPLANTS. Classified as Blade-form Endosseous Dental Implant (product code NRQ), Class II - Special Controls.

Submitted by Leonard P. Linkow, D.D.L. (Mchenry, US). The FDA issued a Cleared decision on November 4, 1982 after a review of 27 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 Leonard P. Linkow, D.D.L. devices

Submission Details

510(k) Number K822969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1982
Decision Date November 04, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 127d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRQ Blade-form Endosseous Dental Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
Definition Device Made Of A Material Such As Titanium Or Titanium Alloy, That Is Intended To Be Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Prosthetic Devices, Such As Artificial Teeth, In Order To Restore A Patient's Chewing Function.
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.