Cleared Special

K052272 - STRAUMANN COMPUTER AIDED RESTORATION SE...

K052272 is the FDA 510(k) clearance for STRAUMANN COMPUTER AIDED RESTORATION SE... by Straumann USA. It is a Class 2 Dental device (product code NHA) cleared through the Special 510(k) pathway after a 134-day FDA review.

K052272 · Straumann USA · Dental device
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Jan 2006
Decision
134d
Days
Class 2
Risk

K052272 is an FDA 510(k) clearance for the STRAUMANN COMPUTER AIDED RESTORATION SERVICE. 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 Straumann USA (Andover, US). The FDA issued a Cleared decision on January 3, 2006 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Straumann USA devices

Submission Details

510(k) Number K052272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2005
Decision Date January 03, 2006
Days to Decision 134 days
Submission Type Special
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
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 480
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K052272.
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