Shefabone™

FDA UDI

Class II (US FDA UDI)

by Shefabone Inc

Identity

Trade Name: Shefabone™ FDA UDI
Generic Name: Dental bone matrix implant, synthetic FDA UDI
Device Name: Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone graft substitute composed of two phases: sodium calcium phosphate (NaCaPO4) and silica (SiO2). The two phases are sintered together in the form of solid solutions.The SCPC is in the form of porous particles in the size range 90-710 micron.The device is sterlized by Gama radiation. FDA UDI
Model / Reference: SCPC Granules FDA UDI
Description: Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone graft substitute composed of two phases: sodium calcium phosphate (NaCaPO4) and silica (SiO2). The two phases are sintered together in the form of solid solutions.The SCPC is in the form of porous particles in the size range 90-710 micron.The device is sterlized by Gama radiation. FDA UDI

Identifiers

Catalog Number: SCPC-1 FDA UDI
Primary DI / UDI-DI: 05060517850005 FDA UDI
510(k) Number: K153230 FDA UDI
FDA Product Code: LYC FDA UDI
GMDN Term: Dental bone matrix implant, synthetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Centiliter FDA UDI

Category: Dental bone matrix implant, synthetic

Shefabone™ by Shefabone Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shefabone Inc

Sources (1)

FDA UDI af7e9331-40b9-44d0-8248-a440d8a444ad 38 fields · synced May 30, 2026