FDA.reportPublic FDA data

SSW ENDO

Primary DI
D690GPTG15062
Brand
SSW ENDO
Company
Ss White Burs, Inc.
Model
UGPTG1506
Catalog number
GPTG1506
Device description
EXACTGUIDE GUTTA PERCHA 15/.06 - 60 PACK
Published
2025-02-18
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
D690GPTG15062PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(732)905-1100customerservice@sswhitedental.com

Regulatory Flags#

DUNS number
151760014
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
true
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
D6903100450SSW CARBIDEHP-PBUR-1/43100452026-02-16
D6903100470SSW CARBIDEHP-PBUR-13100472026-02-16
D6903100480SSW CARBIDEHP-PBUR-23100482026-02-16
D6903100490SSW CARBIDEHP-PBUR-33100492026-02-16
D6903100500SSW CARBIDEHP-PBUR-43100502026-02-16
D6903100510SSW CARBIDEHP-PBUR-53100512026-02-16
D6903100520SSW CARBIDEHP-PBUR-63100522026-02-16
D6903100530SSW CARBIDEHP-PBUR-73100532026-02-16
D6903100540SSW CARBIDEHP-PBUR-83100542026-02-16
D6903100550SSW CARBIDEHP-PBUR-SC103100552026-02-16
D6903100570SSW CARBIDEHP-PBUR-33-1/23100572026-02-16
D6903100610SSW CARBIDEHP-PBUR-373100612026-02-16
D6903100670SSW CARBIDEHP-PBUR-5583100672026-02-16
D6903100720SSW CARBIDEHP-PBUR-6993100722026-02-16
D6903100730SSW CARBIDEHP-PBUR-7003100732026-02-16
D6903100740SSW CARBIDEHP-PBUR-7013100742026-02-16
D6903100750SSW CARBIDEHP-PBUR-7023100752026-02-16
D6903100770SSW CARBIDEHP-PBUR-7033100772026-02-16
D6903100930SSW CARBIDEFG-PBUR-1/23100932026-02-16
D6903100950SSW CARBIDEFG-PBUR-13100952026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978880221102ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221119ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221126ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221133ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
06978880221140ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
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