C-Graft

FDA 510(k) K033110 · The Clinician'S Preference, LLC

Substantially Equivalent

510(k) numberK033110

Submission

Device name
C-Graft
Applicant
The Clinician'S Preference, LLC
San Francisco, CA, US
Received
September 30, 2003
Decision date
December 10, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LYC – Bone Grafting Material, Synthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

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.

Other 510(k)s with product code LYC

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K253317Cytrans™ ElashieldLYC · Traditional GC America, Inc.07/06/2026SE
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K251818Bontree PlusLYC · Traditional Hudens Bio Co., Ltd.03/06/2026SE
K244006FG Bone Graft MLYC · Traditional Full Golden Biotech Co., Ltd.09/17/2025SE
K243745FG Bone Graft BLYC · Traditional Full Golden Biotech Corporation08/29/2025SE
K241186Synthetic Bone Graft ParticulateLYC · Traditional Shenzhen Dazhou Medical Technology Co., Ltd.02/21/2025SE
K213260CMFlexTMLYC · Traditional Dimension Inx Corp.12/30/2022SE
K202675InRoad® Dental Synthetic Bone GraftLYC · Traditional Osteogene Tech Corp03/04/2022SE
K201546OsOpia Synthetic Bone Void FillerLYC · Traditional Revisios BV10/02/2020SE
K201051Straumann BoneCeramicLYC · Traditional Institut Straumann AG09/24/2020SE

Questions and answers

When was C-Graft cleared by the FDA?

C-Graft (K033110) received a 510(k) decision of Substantially Equivalent on December 10, 2003, 71 days after the submission was received.

What is the product code of K033110?

The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.