Cleared Traditional

K942946 - OSTEOGRAF/D-100 HYDROXYLAPATITE

K942946 is an FDA 510(k) clearance for OSTEOGRAF/D-100 HYDROXYLAPATITE, manufactured by Ceramed Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K942946 · Ceramed Corp. · Dental device
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Oct 1994
Decision
104d
Days
Class 2
Risk

K942946 is an FDA 510(k) clearance for the OSTEOGRAF/D-100 HYDROXYLAPATITE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Ceramed Corp. (Lakewood, US). The FDA issued a Cleared decision on October 5, 1994 after a review of 104 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 Ceramed Corp. devices

FDA 510(k) Submission Details - K942946

510(k) Number K942946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date October 05, 1994
Days to Decision 104 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
23d faster than avg
Panel avg: 127d · This submission: 104d
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 122
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K942946.
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K943186 · Lifecore Biomedical, Inc. · Apr 1995
RESOLUT REGENERATIVE MATERIAL
K932866 · W.L. Gore & Associates, Inc. · Mar 1995
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
K950165 · Interpore Intl. · Mar 1995
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K942212 · Ceramed Corp. · Aug 1994
BII-PORE
K933688 · Bio-Interfaces, Inc. · Jul 1994
BII-PORE(TM) CANAL WALL PROSTHESIS
K934049 · Bio-Interfaces, Inc. · Jul 1994