FDA.reportPublic FDA data

Harvard PremiumSil Heavy

Primary DI
EHAR70837311
Brand
Harvard PremiumSil Heavy
Company
Harvard Dental International GmbH
Model
7083731
Device description
Vinylpolysiloxane impression material, super hydrophilic, heavy bodied, type 2
Published
2016-09-15
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
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012767000S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIALS & C Polymer GmbH2001-11-01ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EHAR70837311PrimaryHIBCC0
7083731Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

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
2
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
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
EHAR70836031Harvard InterLock70836032016-09-15

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