FDA.report

Inspire™ Esthetic Provisional Composite A2

Primary DI
07540172010757
Brand
Inspire™ Esthetic Provisional Composite A2
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
152076
Catalog number
152076
Device description
Crown and Bridge Temporary Resin
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
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172010757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172010757075401720107577540172010757

GMDN Terms

TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume10Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature; do not expose to sunlight and avoid exposure to extreme temperature fluctuations. Do not store in refrigerator.
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature64 Degrees Fahrenheit77 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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