FDA.reportPublic FDA data

GUTTA PERCHA POINTS

Primary DI
08806383501774
Brand
GUTTA PERCHA POINTS
Company
DiaDent Group International
Model
ISO 20
Catalog number
101-604
Device description
Gutta Percha Points is used to root canal filing material.
Published
2020-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08806383501774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383501774088063835017748806383501774

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from flammable and combustible materials and heat
Special Storage Condition, Specify00Keep Dry and away from Sunlight
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687789453
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806383525039DIA-X FILE19mm DX571-S1002026-06-15
08806383525046DIA-X FILE21mm D1571-S1012026-02-20
08806383525077DIA-X FILE21mm D4571-S1042026-02-20
08806383525084DIA-X FILE21mm D5571-S1052026-02-20
08806383525091DIA-X FILE21mm D1/D4 Asst571-S1912026-02-20
08806383525107DIA-X FILE19mm/21mm DX/D3 Asst571-S1922026-02-20
08806383525114DIA-X FILE25mm D1571-S2012026-02-20
08806383525121DIA-X FILE25mm D2571-S2022026-02-20
08806383525138DIA-X FILE25mm D3571-S2032026-02-20
08806383525145DIA-X FILE25mm D4571-S2042026-02-20
08806383525152DIA-X FILE25mm D5571-S2052026-02-20
08806383525169DIA-X FILE25mm D1/D4 Asst571-S2912026-02-20
08806383525176DIA-X FILE19mm/25mm DX/D3 Asst571-S2922026-02-20
08806383591690DIACEM TEMPNEDIACEM TEMPNE 3g(Type S)A2004-69122026-05-13
08806383591706DIACEM TEMPNEDIACEM TEMPNE 10g(Type S)A2004-69132026-05-13
06944835131147DIA-X FILE21mm D1/D4 Asst571-S1912026-02-20
06944835131154DIA-X FILE25mm D1/D4 Asst571-S2912026-02-20
06944835131338DIA-X FILE19mm/21mm DX/D3 Asst571-S1922026-02-20
06944835131345DIA-X FILE19mm/25mm DX/D3 Asst 571-S2912026-02-20
06944835173291DIA-X FILE19mm DX571-S1002026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800069213814Edge One R GPSURE DENT CORPORATIONEKM2026-06-22
08800069213302GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213319GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213326GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213333GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213340GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213357GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213364GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213371GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213388GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213395GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213401GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213418GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213425GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213432GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213449GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213456GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213104Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213111Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213128Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213135Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069204775B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204782B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204799B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069205000B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204805XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204812XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204829XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204836XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204843XP-4DSURE DENT CORPORATIONEKM2025-01-07