FDA.report

Harvard Temp C&B A3

Primary DI
EHAR70816531
Brand
Harvard Temp C&B A3
Company
Harvard Dental International GmbH
Model
7081653
Device description
Temporary crown and bridge material 10:1
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EHAR70816531PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+493099289780info@harvard-dental-international.de

Regulatory Flags

DUNS number
341553293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
EHAR177081Harvard Temp Cem177082016-09-15
EHAR177201Harvard Implant Semi-permanent177202016-09-15
EHAR177221Harvard Temp C&B A2177222016-09-15
EHAR177241Harvard ZirconCore A3177242016-09-15
EHAR177271Harvard Ionoresin Fill OptiCaps A2177272016-09-18
EHAR177291Harvard Ionoglas Fill Extra OptiCaps A2177292016-09-18

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