Cleared Traditional

K832509 - MBS HARD TISSUE REPLACEMENT SYSTEM

K832509 is an FDA 510(k) clearance for MBS HARD TISSUE REPLACEMENT SYSTEM, manufactured by Medical Biological Sciences, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K832509 · Medical Biological Sciences, Inc. · Dental device
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Nov 1983
Decision
125d
Days
Class 2
Risk

K832509 is an FDA 510(k) clearance for the MBS HARD TISSUE REPLACEMENT SYSTEM. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Medical Biological Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1983 after a review of 125 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 Medical Biological Sciences, Inc. devices

FDA 510(k) Submission Details - K832509

510(k) Number K832509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date November 29, 1983
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 128d · This submission: 125d
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 187
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K832509.
TOOTH ROOT SOCKET GAUGE
K843154 · Interpore Intl. · Oct 1984
ANTERIOR ALVEOLAR RIDGE SIZER
K843153 · Interpore Intl. · Sep 1984
POROUS HYDROXYAPATITE BG200
K841201 · Interpore Intl. · Aug 1984
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · Depuy, Inc. · Aug 1982
HYDROXYLAPATITE
K811101 · Carbomedics, Inc. · Nov 1981
HYDROXYLAPATITE ALVEOLAR RIDGE MAIN
K810382 · Carbomedics, Inc. · Mar 1981