FDA.reportPublic FDA data

Gutapercha BlueShaper Z6

Primary DI
00810092938903
Brand
Gutapercha BlueShaper Z6
Company
NUSMILE, LTD.
Model
GP-147
Device description
60 units
Published
2022-07-14
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

Contact Domains#

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
00810092938903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810092938903008100929389038100929389030810092938903

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
832-540-5964plara@nusmile.com

Regulatory Flags#

DUNS number
185497372
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810118103650Zarc by Avalon Biomed Gutta Perch Obturator (Pellets)63440032026-01-15
00810118105555Ultradent MTApex 5.0 g Powder138692026-01-14
00810118105562Ultradent MTApex 5.0 ml Gel138682026-01-14
00810118106620EdgeEndo Biocermaic Sealer TipNEOPROT2026-01-14
00810118106637Dentsply ProRoot Flex TipPRFT202026-01-14
00810118106644NuSmile ReVIVE CrownsSK704L2025-11-26
00810118106651NuSmile ReVIVE CrownsPK704L2025-11-26
00810118106682NuSmile ReVIVE CrownsPK706L2025-11-26
00810118106842NuSmile ReVIVE CrownsLC1704L2025-11-26
00810118106859NuSmile ReVIVE CrownsLC2704L2025-11-26
00810118106866NuSmile ReVIVE CrownsLC3704L2025-11-26
00810118106873NuSmile ReVIVE CrownsLC4704L2025-11-26
00810118106880NuSmile ReVIVE CrownsLC5704L2025-11-26
00810118106897NuSmile ReVIVE CrownsU1704L2025-11-26
00810118106903NuSmile ReVIVE CrownsU2704L2025-11-26
00810118106910NuSmile ReVIVE CrownsU3704L2025-11-26
00810118106927NuSmile ReVIVE CrownsU4704L2025-11-26
00810118106934NuSmile ReVIVE CrownsDLL1706L2025-11-26
00810118106941NuSmile ReVIVE CrownsDLL2706L2025-11-26
00810118106958NuSmile ReVIVE CrownsDLL3706L2025-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06978880221157ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221164ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221171ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221188ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221195ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221201ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221218ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221225ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221232ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221249ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221256ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221263ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221270ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221287ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221294ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221300ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221317ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221324ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221331ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221348ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221355ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221362ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221379ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221386ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221393ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09