CMFlex

FDA UDI

Class II (US FDA UDI)

by Dimension INX Corp

Identity

Trade Name: CMFlex FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: CMFlex Block for bone graft 38 x 38 x 9 (mm) FDA UDI
Model / Reference: CMFB13 FDA UDI
Description: CMFlex Block for bone graft 38 x 38 x 9 (mm) FDA UDI

Identifiers

Primary DI / UDI-DI: 00860009902008 FDA UDI
510(k) Number: K213260 FDA UDI
FDA Product Code: LYC FDA UDI
GMDN Term: Synthetic bone graft 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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 38 Millimeter FDA UDI
Width — 38 Millimeter FDA UDI
Height — 9 Millimeter FDA UDI

Category: Synthetic bone graft

CMFlex by Dimension INX Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Osbone Dental — curasan AG · Class II
Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II

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: Dimension INX Corp

Sources (1)

FDA UDI e43e3362-5237-41ef-8bec-cecf921a1d85 37 fields · synced Jun 8, 2026