FDA.reportPublic FDA data

SSW CARBIDE GREAT WHITE

Primary DI
D690107072
Brand
SSW CARBIDE GREAT WHITE
Company
Ss White Burs, Inc.
Model
FG-PBUR-GW557SL
Catalog number
10707
Device description
GREAT WHITE GOLD CARBIDE GWSL 557 - STERILE ROLL 25
Published
2025-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D690107072PrimaryHIBCC0
D690107070Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, single-useA 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 single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
151760014
Device count
25
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
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049901612DIA-ZDiaswiss SAEJL2023-10-02
07630049902077Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07