Cleared Traditional

K821752 - SYNTHOGRAFT LG-AUGMENTATION & BONE FILL

K821752 is an FDA 510(k) clearance for SYNTHOGRAFT LG-AUGMENTATION & BONE FILL, manufactured by Depuy, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K821752 · Depuy, Inc. · Dental device
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Aug 1982
Decision
58d
Days
Class 2
Risk

K821752 is an FDA 510(k) clearance for the SYNTHOGRAFT LG-AUGMENTATION & BONE FILL. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1982 after a review of 58 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K821752

510(k) Number K821752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1982
Decision Date August 12, 1982
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 127d · This submission: 58d
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 171
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K821752.
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
HYDROXYLAPATITE
K811101 · Carbomedics, Inc. · Nov 1981
HYDROXYLAPATITE ALVEOLAR RIDGE MAIN
K810382 · Carbomedics, Inc. · Mar 1981
PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT
K791416 · Carbomedics, Inc. · Oct 1979