FDA.reportPublic FDA data

Harvard PremiumFill A1

Primary DI
EHAR70822011
Brand
Harvard PremiumFill A1
Company
Harvard Dental International GmbH
Model
7082201
Device description
Universal light cure nano-hybrid composite for restorations
Published
2016-10-21
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
EHAR70822011PrimaryHIBCC0

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630243601301ParaCoreDent4You AGEBF2026-07-07
07630243634743ParaCoreDent4You AGEBF2026-07-07
07630243634750ParaCoreDent4You AGEBF2026-07-07
07630243634767ParaCoreDent4You AGEBF2026-07-07
07630243634774ParaCoreDent4You AGEBF2026-07-07
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
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06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
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06975338702992SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703005SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
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06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02