FDA.report

REVELATION DIAMOND

Primary DI
D6909110950
Brand
REVELATION DIAMOND
Company
Ss White Burs, Inc.
Model
Z-10839-012M
Catalog number
911095
Device description
REVELATION DIAMOND 809-012M - 5 PACK
Published
2025-02-19
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

Product Codes

CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6909110952PrimaryHIBCC0
D6909110950Unit 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
5
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

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D6903100480SSW CARBIDEHP-PBUR-23100482026-02-16
D6903100490SSW CARBIDEHP-PBUR-33100492026-02-16
D6903100500SSW CARBIDEHP-PBUR-43100502026-02-16
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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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