FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919505587
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5008941U0
Device description
UNIV OF MISS WAX INST KIT 1P
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELJTEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELJTeeth, Artificial, Posterior With Metal InsertDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919505587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919505587008879195055878879195055870887919505587

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable 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
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720604633771Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633788Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633795Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633801Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633818Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633825Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08719425508924Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508948Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508955Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508962Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508979Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508986Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
06975409642004CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
06975409643001CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
06975409644008CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
00887919558736Brasseler USAPeter Brasseler Holdings, LLCELJ2022-12-08
00887919571919Brasseler USAPeter Brasseler Holdings, LLCELJ2022-12-08
08800003006052RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006069RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006076RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006083RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006004RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006011RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006028RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006035RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006042RAYDENT C&BRay Co., LtdELJ2022-11-03
00850039704178OnX Tough - Hollywood BleachSprintray, Inc.ELJ2022-10-04
00850039704079OnX - BleachSprintray, Inc.ELJ2022-02-28
00850039704086OnX - A1Sprintray, Inc.ELJ2022-02-28
00850039704093OnX - B1Sprintray, Inc.ELJ2022-02-28