FDA.report

StarDental Instrument Solutions

Primary DI
D7022002520
Brand
StarDental Instrument Solutions
Company
DENTALEZ, INC.
Model
200252
Device description
CLASSIQUE DIA INSTRUMENTS 556-4P
Published
2018-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7022002520PrimaryHIBCC0
D702200252Unit of UseHIBCC0

GMDN Terms

TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-866-383-4636xx@xx.xx

Regulatory Flags

DUNS number
059010363
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D7022663420StarDental2663422663422025-06-20
D7022663430StarDental2663432025-06-20
D7022663450StarDental2663452025-06-20
D7022664900StarDental2664902025-06-20
D7022601520StarDental Instrument Solutions2601522018-11-05
D702RT3001050StarDental Instrument SolutionsRT3-001052016-09-13
D7022637580StarDental Instrument Solutions2637582018-11-05
D7022637720StarDental Instrument Solutions2637722018-11-05
D7022637730StarDental Instrument Solutions2637732018-11-05
D7022654000StarDental Instrument Solutions2654002018-11-05
D7022656460StarDental Instrument Solutions2656462018-11-05
D7022688420StarDental Instrument Solutionss2688422018-11-05
D7022688430StarDental Instrument Solutions2688432018-11-05
D7022639810StarDental Instrument Solutions2639812023-07-14
D7022639820StarDental Instrument Solutions2639822023-07-14
D7022639830StarDental Instrument Solutions2639832023-07-14
D7020659900StarDental Instrument Solutions0659902018-11-05
D7020659910StarDental Instrument Solutions0659912018-11-05
D7022625830StarDental Instrument Solutions2625832018-11-05
D7022639720StarDental Instrument Solutions2639722018-11-05

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B868CV1600050Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
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D690W368021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W801016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801023M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W802016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W805014C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W811031M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16