Cleared Special

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK (K033630) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033630 · Rhein 83 Srl · Dental device
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Apr 2004
Decision
156d
Days
Class 2
Risk

K033630 is an FDA 510(k) clearance for the MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Rhein 83 Srl (Hoboken, US). The FDA issued a Cleared decision on April 21, 2004 after a review of 156 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rhein 83 Srl devices

Submission Details

510(k) Number K033630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2003
Decision Date April 21, 2004
Days to Decision 156 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 305
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