FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919762676
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5025569U0
Device description
VFD1SM VERSAFLEX SM (SC) 100P
Published
2024-08-01
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
EHMSTRIP, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919762676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919762676008879197626768879197626760887919762676

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. 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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00887919749981Brasseler USA5025306U05025306U02023-01-25
00887919752301Brasseler USA5025362U05025362U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535030334Brasseler USAPeter Brasseler Holdings, LLCEHM2026-09-25
08404535030365Brasseler USAPeter Brasseler Holdings, LLCEHM2026-09-25
08404535030396Brasseler USAPeter Brasseler Holdings, LLCEHM2026-09-25
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ESUN46718Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46728Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46738Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46748Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46768Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46778Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46808Jiffy proximal sawDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46838Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3541008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354LD8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3568Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF356L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3638Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3648Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3668Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF37258Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3738Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF373D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3748Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30