FDA.report

Pro-V C&B A3 50ml Syr.

Primary DI
D757H403A30
Brand
Pro-V C&B A3 50ml Syr.
Company
BISCO INC.
Model
H-403A3
Catalog number
H-403A3
Published
2018-11-21
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
D757H403A30PrimaryHIBCC0

GMDN Terms

TermDefinition
Preformed dental crown, temporaryA prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(847)534-6000sales@bisco.com

Regulatory Flags

DUNS number
053529939
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

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