FDA.report

A.B. Universal - 50 ct. Unit Dose Kit

Primary DI
D757B73050K1
Brand
A.B. Universal - 50 ct. Unit Dose Kit
Company
BISCO INC.
Model
B-73050K
Catalog number
B-73050K
Published
2017-06-12
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
true

Related Records

Contact Domains

Product Codes

CodeName
KXRAPPLICATOR, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D757B73050K1PrimaryHIBCC0

GMDN Terms

TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 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
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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