Cleared Traditional

K220978 - TSX Implants

K220978 is an FDA 510(k) clearance for TSX Implants, manufactured by Biomet 3i, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K220978 · Biomet 3i, LLC · Dental device
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Sep 2022
Decision
163d
Days
Class 2
Risk

K220978 is an FDA 510(k) clearance for the TSX Implants. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomet 3i, LLC (Palm Beach Gardens, US). The FDA issued a Cleared decision on September 14, 2022 after a review of 163 days - an extended review 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: 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 Biomet 3i, LLC devices

FDA 510(k) Submission Details - K220978

510(k) Number K220978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date September 14, 2022
Days to Decision 163 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
36d slower than avg
Panel avg: 127d · This submission: 163d
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.

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All 758
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