Cleared Special

K033630 - MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK

K033630 is an FDA 510(k) clearance for MODIFICATION OF: SPHERO FLEX, manufactured by Rhein 83 Srl. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 156-day FDA review.

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.

FDA 510(k) Submission Details - K033630

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 128d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1424
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