FDA.report

Ceri-Prime

Primary DI
D8131002AB0
Brand
Ceri-Prime
Company
DEN-MAT HOLDINGS, LLC
Model
1002AB
Catalog number
1002AB
Device description
PORC CONDITIONER 6g
Published
2016-09-24
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

Product Codes

CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8131002AB0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature47 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00 Cold storage is not required
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00Keep out of direct sunlight
Special Storage Condition, Specify00Store in a cool, dry location.
Storage Environment Temperature47 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags

DUNS number
809857704
Device count
1
DM exempt
false
Premarket exempt
true
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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