Provi Bond, 5 ml

Primary DI
EBIB037101
Brand
Provi Bond, 5 ml
Company
bisico Bielefelder Dentalsilicone GmbH & Co. KG
Model
03710
Catalog number
03710
Device description
temporary cement, non eugenol
Published
2018-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973201000PROVI CEMENTS & C Polymer GmbH1998-06-05EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBIB037101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Zinc polycarboxylate dental cementA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature8 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature8 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+495218016800info@bisico.de

Regulatory Flags#

DUNS number
316133664
Device count
1
Lot or batch
true
Expiration date on label
true

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