Cleared Traditional

K142211 - OT EQUATOR

K142211 is an FDA 510(k) clearance for OT EQUATOR, manufactured by Rhein 83 Srl. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 470-day FDA review.

K142211 · Rhein 83 Srl · Dental device
Download Printable Device Report (PDF)
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Nov 2015
Decision
470d
Days
Class 2
Risk

K142211 is an FDA 510(k) clearance for the OT EQUATOR. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Rhein 83 Srl (Bologna, IT). The FDA issued a Cleared decision on November 25, 2015 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 Rhein 83 Srl devices

FDA 510(k) Submission Details - K142211

510(k) Number K142211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2014
Decision Date November 25, 2015
Days to Decision 470 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
343d slower than avg
Panel avg: 127d · This submission: 470d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 559
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