FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919236306
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
005207U0
Device description
30006.31.060 (M) RD TAP 5P
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
00887919236306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919236306008879192363068879192363060887919236306

GMDN Terms#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535019247Brasseler USA5031780U05031780U02026-03-24
08404535024906Brasseler USA5032029U05032029U02026-03-23
08404535024937Brasseler USA5032030U05032030U02026-03-23
08404535024968Brasseler USA5032031U05032031U02026-03-23
08404535025156LARGE BONE BLADESBR1-12100-50BR1-12100-502026-03-23
08404535024579Brasseler USAFL17CHP5032016U02026-03-17
08404535024609Brasseler USAFL17MHP5032017U02026-03-17
08404535024630Brasseler USAFL17FHP5032018U02026-03-17
08404535024661Brasseler USAFL17UF5032019U02026-03-17
08404535021769BrioPrep Sterile Diamonds5031856U05031856U02025-11-21
08404535021790BrioPrep Sterile Diamonds5031857U05031857U02025-11-21
08404535021820BrioPrep Sterile Diamonds5031858U05031858U02025-11-21
08404535021851BrioPrep Sterile Diamonds5031859U05031859U02025-11-21
08404535021882BrioPrep Sterile Diamonds5031860U05031860U02025-11-21
08404535021912BrioPrep Sterile Diamonds5031861U05031861U02025-11-21
08404535021943BrioPrep Sterile Diamonds5031862U05031862U02025-11-21
08404535021974BrioPrep Sterile Diamonds5031863U05031863U02025-11-21
08404535022001BrioPrep Sterile Diamonds5031864U05031864U02025-11-21
08404535022124BrioPrep Sterile Diamonds5031880U05031880U02025-11-21
08404535022155BrioPrep Sterile Diamonds5031881U05031881U02025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B868CV1600010Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600020Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600030Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600040Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600050Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600060Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
D690W368021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801009M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801012M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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
D690W802014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W802016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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