FDA.reportPublic FDA data

Harvard Restore A2 opaque

Primary DI
EHAR70832101
Brand
Harvard Restore A2 opaque
Company
Harvard Dental International GmbH
Model
7083210
Device description
Light cure universal microhybrid composite
Published
2016-09-02
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EHAR70832101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+493099289780info@harvard-dental-international.de

Regulatory Flags#

DUNS number
341553293
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EHAR70540001Harvard Etch70540002016-09-15
EHAR70837011Harvard PremiumSil Light70837012016-09-15
EHAR70837021Harvard PremiumSil Light Fast70837022016-09-15
EHAR70837111Harvard PremiumSil Medium70837112016-09-15
EHAR70837121Harvard PremiumSil Medium Fast70837122016-09-15
EHAR70837211Harvard PremiumSil Mono70837212016-09-15
EHAR70837221Harvard PremiumSil Mono Fast70837222016-09-15
EHAR70837311Harvard PremiumSil Heavy70837312016-09-15
EHAR70837321Harvard PremiumSil Heavy Fast70837322016-09-15
EHAR70837331Harvard PremiumSil Heavy MaxiMix70837332016-09-15
EHAR70837401Harvard PremiumSil Putty Soft MaxiMix70837402016-09-15
EHAR70837411Harvard PremiumSil Putty Soft70837412016-09-15
EHAR70837421Harvard PremiumSil Putty Soft Fast70837422016-09-15
EHAR70837511Harvard PremiumSil Putty70837512016-09-15
EHAR70837521Harvard PremiumSil Putty Fast70837522016-09-15
EHAR177351Harvard Bond SE Dual177352016-09-15
EHAR177661Harvard Bond SE Mono177662016-09-15
EHAR70832181Harvard Self-Bond70832182016-09-15
EHAR70836011Harvard Bond SE Mono70836012016-09-15
EHAR70836021Harvard Bond SE Dual70836022016-09-15

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