FDA.reportPublic FDA data

Pro-V C&B A3 50ml Syr. Refill Pkg

Primary DI
D757H403A3P1
Brand
Pro-V C&B A3 50ml Syr. Refill Pkg
Company
BISCO INC.
Model
H-403A3P
Catalog number
H-403A3P
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757H403A3P1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius24 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00810111543330QuantiumH-110A2SH-110A2S2025-07-29
00810111543347QuantiumH-110A2PSH-110A2PS2025-07-29
10810111541500Aelite Aesthetic EnamelH-852B4H-852B42023-01-16
10810111541548Aelite Aesthetic EnamelH-852FRH-852FR2023-01-16
10810111542255eCementC-5201C-52012023-01-17
20810111541606Aelite Aesthetic EnamelH-854A4H-854A42023-01-16
20810111541637Aelite Aesthetic EnamelH-854B3H-854B32023-01-16
20810111541644Aelite Aesthetic EnamelH-854B4H-854B42023-01-16
20810111541651Aelite Aesthetic EnamelH-854D2H-854D22023-01-16
20810111541668Aelite Aesthetic EnamelH-854D4H-854D42023-01-16
20810111541682Aelite Aesthetic EnamelH-854FRH-854FR2023-01-16
10810111542996QuantiumH-100A1H-100A12025-07-14
10810111543009QuantiumH-100A2H-100A22025-07-14
10810111543016QuantiumH-100A3H-100A32025-07-14
10810111543023QuantiumH-100A35H-100A352025-07-14
10810111543030QuantiumH-100B1H-100B12025-07-14
10810111543047QuantiumH-100B2H-100B22025-07-14
10810111543054QuantiumH-130BLCH-130BLC2025-07-14
10810111543061QuantiumH-110A1H-110A12025-07-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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