FDA.reportPublic FDA data

GREAT WHITE Z DIAMOND

Primary DI
D690647642
Brand
GREAT WHITE Z DIAMOND
Company
Ss White Burs, Inc.
Model
U-GWZ 801-018F
Catalog number
64764
Device description
GREAT WHITE Z 801-018 SAMPLE - 1 PACK
Published
2025-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D690647642PrimaryHIBCC0

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D6903100452SSW CARBIDEHP-PBUR-1/43100452026-02-16
D6903100472SSW CARBIDEHP-PBUR-13100472026-02-16
D6903100482SSW CARBIDEHP-PBUR-23100482026-02-16
D6903100492SSW CARBIDEHP-PBUR-33100492026-02-16
D6903100502SSW CARBIDEHP-PBUR-43100502026-02-16
D6903100512SSW CARBIDEHP-PBUR-53100512026-02-16
D6903100522SSW CARBIDEHP-PBUR-63100522026-02-16
D6903100532SSW CARBIDEHP-PBUR-73100532026-02-16
D6903100542SSW CARBIDEHP-PBUR-83100542026-02-16
D6903100552SSW CARBIDEHP-PBUR-SC103100552026-02-16
D6903100572SSW CARBIDEHP-PBUR-33-1/23100572026-02-16
D6903100612SSW CARBIDEHP-PBUR-373100612026-02-16
D6903100672SSW CARBIDEHP-PBUR-5583100672026-02-16
D6903100722SSW CARBIDEHP-PBUR-6993100722026-02-16
D6903100732SSW CARBIDEHP-PBUR-7003100732026-02-16
D6903100742SSW CARBIDEHP-PBUR-7013100742026-02-16
D6903100752SSW CARBIDEHP-PBUR-7023100752026-02-16
D6903100772SSW CARBIDEHP-PBUR-7033100772026-02-16
D6903100932SSW CARBIDEFG-PBUR-1/23100932026-02-16
D6903100952SSW CARBIDEFG-PBUR-13100952026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919227335Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
00887919317036Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029468Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029499Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029529Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029550Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029581Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029611Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029642Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029673Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029703Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029734Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029765Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029796Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029826Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029857Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029888Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029918Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029949Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029970Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
ESUN379P3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801C2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801F3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23