FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919888000
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5028633U0
Device description
EZ234 LEGEND CROWN SPREADER 1P
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EISREMOVER, CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919888000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919888000008879198880008879198880000887919888000

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis handling forcepsA hand-held manual dental instrument designed for grasping and holding a dental implant and/or prosthesis (e.g., crown, bridge, screw) during its application to a patient's oral cavity. It typically has a tweezers-like design consisting of two conjoined blades with serrated tips at the working end; some types have graduated markings on the tips for gauging. It is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in various sizes. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955CRO27041Paul BandittTerlain Enterprises, Inc.EIS2026-09-28
G149TBSB4270TBS BASICSACME ENTERPRISE.EIS2026-05-20
00348783010114Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010121Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010138Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010145Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010152Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010169Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
00348783010176Premier Crown RemoversPREMIER DENTAL PRODUCTS COMPANYEIS2026-04-02
G14934001F08TBS DentalACME ENTERPRISE.EIS2026-03-02
04963931210794NAYDM CORPORATIONEIS2025-12-05
04963931210800NAYDM CORPORATIONEIS2025-12-05
00841336106086Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108646Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108660Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
08800075627346OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
08800075627353OSUNG MNDOSUNG MND Co., Ltd.EIS2025-11-03
00841336100916Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125551Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125568Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125599Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
06974456210815CICADAFoshan Cicada Dental Instrument Co., Ltd.EIS2024-08-10
00813677025098PDT, Inc.PDT, INC.EIS2024-07-03
00813677023292PDT, Inc.PDT, INC.EIS2024-07-02
00813677024565PDT, Inc.PDT, INC.EIS2024-07-02
00813677023285PDT, Inc.PDT, INC.EIS2024-07-01
00813677023544PDT, Inc.PDT, INC.EIS2024-07-01
00813677023551PDT, Inc.PDT, INC.EIS2024-07-01