FDA.report

MPa™ Max Adhesive with Chlorhexidine

Primary DI
07540172010771
Brand
MPa™ Max Adhesive with Chlorhexidine
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
266506
Catalog number
266506
Device description
Dental Bonding Agent
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172010771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172010771075401720107717540172010771

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
Total Volume5Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags

DUNS number
626406016
Device count
1
DM exempt
true
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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