Cleared Traditional

K092788 - PERIOPHIL BIPHASIC

K092788 is an FDA 510(k) clearance for PERIOPHIL BIPHASIC, manufactured by Cytophil, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K092788 · Cytophil, Inc. · Dental device
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Dec 2009
Decision
99d
Days
Class 2
Risk

K092788 is an FDA 510(k) clearance for the PERIOPHIL BIPHASIC. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Cytophil, Inc. (East Troy, US). The FDA issued a Cleared decision on December 18, 2009 after a review of 99 days - within the typical 510(k) review window.

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.

View all Cytophil, Inc. devices

FDA 510(k) Submission Details - K092788

510(k) Number K092788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2009
Decision Date December 18, 2009
Days to Decision 99 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 127d · This submission: 99d
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 65
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K092788.
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K093390 · Depuy Spine, Inc. · May 2010
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K100671 · Novabone Products, LLC · Mar 2010
MEDTRONIC DENTAL TCP
K092087 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K091484 · Novabone Products, LLC · Jun 2009
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K083742 · Collagen Matrix, Inc. · Feb 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · Medtronic Sofamor Danek · Jan 2009