Cleared Traditional

K052493 - SOCKET GRAFT

K052493 is an FDA 510(k) clearance for SOCKET GRAFT, manufactured by Steiner Laboratories. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K052493 · Steiner Laboratories · Dental device
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Jun 2006
Decision
270d
Days
Class 2
Risk

K052493 is an FDA 510(k) clearance for the SOCKET GRAFT. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Steiner Laboratories (Kapolei, US). The FDA issued a Cleared decision on June 9, 2006 after a review of 270 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 - K052493

510(k) Number K052493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2005
Decision Date June 09, 2006
Days to Decision 270 days
Submission Type Traditional
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
142d slower than avg
Panel avg: 128d · This submission: 270d
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 K052493.
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
K063596 · Novabone Products, LLC · Feb 2007
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K063549 · Novabone Products, LLC · Feb 2007
REGEN BIOCEMENT
K063010 · Steiner Laboratories · Nov 2006
MBCP GEL
K060732 · Biomatlante · Jun 2006
BONEGEN - TR
K060285 · Bio-Lok Intl., Inc. · Mar 2006
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
K053374 · Ossacur AG · Feb 2006