FDA.report

SSW CARBIDE

Primary DI
D690120120
Brand
SSW CARBIDE
Company
Ss White Burs, Inc.
Model
HP-PBUR-1/2
Catalog number
12012
Device description
HP CARBIDE 1/2 - BULK 100
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

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D690120122PrimaryHIBCC0
D690120120Unit of UseHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
+1(732)905-1100customerservice@sswhitedental.com

Regulatory Flags

DUNS number
151760014
Device count
100
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 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

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