Cleared Special

K113282 - CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO

K113282 is an FDA 510(k) clearance for CERASORB DENTAL, manufactured by Riemser Arzeimittel AG. The device is a Class 2 Dental device with product code LYC cleared through the Special 510(k) pathway after a 318-day FDA review.

K113282 · Riemser Arzeimittel AG · Dental device
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Sep 2012
Decision
318d
Days
Class 2
Risk

K113282 is an FDA 510(k) clearance for the CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Riemser Arzeimittel AG (Durham, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Riemser Arzeimittel AG devices

FDA 510(k) Submission Details - K113282

510(k) Number K113282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date September 20, 2012
Days to Decision 318 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 127d · This submission: 318d
Pathway characteristics
Modification to existing cleared device.

LYC Device Classification - Class 2, Special Controls

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
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 - LYC Bone Grafting Material, Synthetic

All 104
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K113282.
Cytrans Granules
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BONE PLUS BCP EAGLE EYE
K122240 · Megagen Implant Co., Ltd. · Aug 2012
OSTEON II
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NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
K112428 · Novabone Products, LLC · Dec 2011