Cleared Traditional

K100883 - CARRIGEN

K100883 is an FDA 510(k) clearance for CARRIGEN, manufactured by Etex Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K100883 · Etex Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
266d
Days
Class 2
Risk

K100883 is an FDA 510(k) clearance for the CARRIGEN. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on December 21, 2010 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K100883

510(k) Number K100883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2010
Decision Date December 21, 2010
Days to Decision 266 days
Submission Type Traditional
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
138d slower than avg
Panel avg: 128d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 202
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K100883.
OSTEOSCAF
K101827 · Texas Innovative Medical Devices (Dba) Skeletal · Apr 2011
CERACELL DENTAL
K103709 · Curasan AG · Mar 2011
OSBONE DENTAL
K102872 · Curasan AG · Jan 2011
GAMMA-BSM
K102812 · Etex Corporation · Dec 2010
OSTEON, OSTEON SINUS, OSTEON LIFTING
K102015 · Genoss Co., Ltd. · Nov 2010
OSSEOCONDUCT
K101718 · Steiner Laboratories Div of Steiner Healthcare, LLC · Oct 2010