BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

HY-Bond Polycarboxylate Temporary Cement

DI: E23511730 · Model: 1173 · SHOFU DENTAL CORPORATION

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: HY-Bond Polycarboxylate Temporary Cement
Primary DI: E23511730
Version / Model: 1173
Catalog Number: 1173
Company Name: SHOFU DENTAL CORPORATION
Labeler DUNS: 054618202
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-23
Public Version: 5
Public Version Date: 2020-11-30
Public Version Status: Update
Public Device Record Key: 50b06284-5166-4f6f-a539-d522a9f09939
Distribution End Date: 2020-11-30

Device Description

HY-BOND POLY TEMP CEM 125/60

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: Labeling does not contain MRI Safety Information
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
16705	Zinc polycarboxylate dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E23511730	HIBCC

Customer Contacts

Phone: 760-566-3528
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002461	000

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 1 – 30 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: 1 – 30 Degrees Celsius