FDA.report

Pro-V C&B Bleach 50ml Syr. Refill Pkg

Primary DI
D757H403BLP1
Brand
Pro-V C&B Bleach 50ml Syr. Refill Pkg
Company
BISCO INC.
Model
H-403BLP
Catalog number
H-403BLP
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
D757H403BLP1PrimaryHIBCC0

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 to serve as a temporary protective device. 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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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