BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Cavex Temporary Cement

DI: E241CE0900 · Model: CE090 · Cavex Holland B.V.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Cavex Temporary Cement
Primary DI: E241CE0900
Version / Model: CE090
Catalog Number: CE090
Company Name: Cavex Holland B.V.
Labeler DUNS: 419980156
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-07-07
Public Version: 3
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: a32a3cf9-1ecb-4581-b49b-552fa4fa01bf

Device Description

Dental Cement

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Safe
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38778	Temporary dental filling material	A dental material of various chemical compositions [e.g., calcium hydroxide (Ca(OH)2), methyl methacrylate] used to temporarily fill tooth cavities to preserve the tooth and its pulp. It is typically x-ray visible and may be used for temporary tooth filling with direct/indirect capping, root treatment with pulp capping, vital amputations, treatment of extirpation, decayed pulps, gangrene, fistulae, sensitive tooth crevices, superficial enamel caries, and marginal periodontium inflammation. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E241CE0900	HIBCC

Customer Contacts

Phone: +31(0)235307700
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K003791	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 pcs

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 0 – 25 Degrees Celsius