Cleared Traditional

K211872 - PiezoImplant System (FDA 510(k) Clearance)

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

K211872 · Rex Implants, Inc. · Dental device
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Oct 2022
Decision
482d
Days
Class 2
Risk

K211872 is an FDA 510(k) clearance for the PiezoImplant System. Classified as Blade-form Endosseous Dental Implant (product code NRQ), Class II - Special Controls.

Submitted by Rex Implants, Inc. (Columbus, US). The FDA issued a Cleared decision on October 12, 2022 after a review of 482 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.

View all Rex Implants, Inc. devices

Submission Details

510(k) Number K211872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2021
Decision Date October 12, 2022
Days to Decision 482 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
355d slower than avg
Panel avg: 127d · This submission: 482d
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.

Regulatory Consultant

Backroads Consulting
Karen E Warden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.