FDA.report

Inspire™ Complete Provisional System Kit

Primary DI
07540172010986
Brand
Inspire™ Complete Provisional System Kit
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
152720W
Catalog number
152720W
Device description
Esthetic Provisional Composite
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
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172010986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172010986075401720109867540172010986

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.

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
true
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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