Cleared Special

K994172 - CEREC 3

K994172 is an FDA 510(k) clearance for CEREC 3, manufactured by Sirona Dental Systems GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Special 510(k) pathway after a 60-day FDA review.

K994172 · Sirona Dental Systems GmbH · Dental device
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Feb 2000
Decision
60d
Days
Class 2
Risk

K994172 is an FDA 510(k) clearance for the CEREC 3. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (North Attleboro, US). The FDA issued a Cleared decision on February 8, 2000 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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. Low regulatory complexity profile. 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 - K994172

510(k) Number K994172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date February 08, 2000
Days to Decision 60 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
68d faster than avg
Panel avg: 128d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 403
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K994172.
FLEXTIME
K000629 · Heraeus Kulzer, Inc. · Apr 2000
DIMENSION GARANT L, DIMENSION GARANT L QUICK
K000588 · Espe Dental AG · Mar 2000
DIMENSION PENTA H, DIMENSION PENTA H QUICK
K000591 · Espe Dental AG · Mar 2000
IMPREGUM PENTA M MONOSOFT
K994192 · Espe Dental AG · Jan 2000
IMPREGUM PENTA DUOSOFT
K994193 · Espe Dental AG · Jan 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · GC America, Inc. · Jan 2000
K994172 · CEREC 3
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