FDA.reportPublic FDA data

Gutta Percha Points

Primary DI
D8090525165Z0
Brand
Gutta Percha Points
Company
ROYDENT DENTAL PRODUCTS INC
Model
0525165Z
Catalog number
0525165Z
Device description
Gutta Percha Points GP ISO Cst CCE 45-80
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EKMGUTTA-PERCHA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8090525165Z1PrimaryHIBCC0
D8090525165Z0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic gutta-perchaA dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
131487225
Device count
120
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
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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D80906319010R0Endodontic Hand Instruments06319010R06319010R2022-11-10
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D80906319025R0Endodontic Hand Instruments06319025R06319025R2022-11-09
D80906319160R0Endodontic Hand Instruments06319160R06319160R2022-11-09
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D80906321008R0Endodontic Hand Instruments06321008R06321008R2022-11-09
D80906321010R0Endodontic Hand Instruments06321010R06321010R2022-11-09
D80906321012R0Endodontic Hand Instruments06321012R06321012R2022-11-09
D80906321015R0Endodontic Hand Instruments06321015R06321015R2022-11-09
D80906321017R0Endodontic Hand Instruments06321017R06321017R2022-11-09
D80906321020R0Endodontic Hand Instruments06321020R06321020R2022-11-09
D80906321025R0Endodontic Hand Instruments06321025R06321025R2022-11-09
D80906321030R0Endodontic Hand Instruments06321030R06321030R2022-11-09
D80906321035R0Endodontic Hand Instruments06321035R06321035R2022-11-09
D80906321040R0Endodontic Hand Instruments06321040R06321040R2022-11-09
D80906321045R0Endodontic Hand Instruments06321045R06321045R2022-11-09
D80906321050R0Endodontic Hand Instruments06321050R06321050R2022-11-09
D80906321055R0Endodontic Hand Instruments06321055R06321055R2022-11-09
D80906321060R0Endodontic Hand Instruments06321060R06321060R2022-11-09

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