FDA.report

GUTTA PERCHA POINTS

Primary DI
08806383553797
Brand
GUTTA PERCHA POINTS
Company
DiaDent Group International
Model
ISO ASST 15/40
Catalog number
C101-S691
Device description
Gutta Percha Points is used to root canal filing material.
Published
2020-04-16
Public version status
New
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

Product Codes

CodeName
EKMGutta-Percha

Product Code Classifications

CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806383553797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806383553797088063835537978806383553797

GMDN Terms

TermDefinition
Natural gutta-perchaA dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and away from Sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
687789453
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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