Cleared Traditional

K972278 - CYTOPLAST REGENTEX TITANIUM 250

K972278 is an FDA 510(k) clearance for CYTOPLAST REGENTEX TITANIUM 250, manufactured by Osteogenics Co.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K972278 · Osteogenics Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
49d
Days
Class 2
Risk

K972278 is an FDA 510(k) clearance for the CYTOPLAST REGENTEX TITANIUM 250. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Osteogenics Co. (Fort Worth, US). The FDA issued a Cleared decision on August 6, 1997 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteogenics Co. devices

FDA 510(k) Submission Details - K972278

510(k) Number K972278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1997
Decision Date August 06, 1997
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
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 123
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K972278.
ENDOBON
K980679 · Biomet, Inc. · Apr 1998
GORE RESOLUT XT REGENERATIVE MATERIAL
K973594 · W.L. Gore & Associates, Inc. · Dec 1997
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
K972842 · Interpore Intl. · Oct 1997
BSM BONE SUBSTITUTE MATERIAL KIT
K962548 · Etex Corp. · Aug 1997
RESOLUT REGENERATIVE MATERIAL
K970884 · W.L. Gore & Associates, Inc. · May 1997
CYTOPLAST GBR
K964342 · Osteogenics Co. · Mar 1997