FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919639800
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5019391U0
Device description
W17HPA DIALITE HP CUP ASST 3P
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
EHLPOINT, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919639800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919639800008879196398008879196398000887919639800

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
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535023398Brasseler USA5031885U05031885U02026-05-13
08404535029406Brasseler USA5032304U05032304U02026-05-13
08404535029437Brasseler USA5032305U05032305U02026-05-13
08404535025101Brasseler USA5032020U05032020U02026-05-11
08404535025927Brasseler USA5032032U05032032U02026-05-01
08404535015003Brasseler USA5031791U05031791U02026-04-29
08404535015126Brasseler USA5031795U05031795U02026-04-29
08404535018929Brasseler USA5031818U05031818U02026-04-29
08404535018950Brasseler USA5031819U05031819U02026-04-29
08404535019049Brasseler USA5031822U05031822U02026-04-29
08404535019070Brasseler USA5031823U05031823U02026-04-29
08404535019100Brasseler USA5031824U05031824U02026-04-29
08404535019131Brasseler USA5031825U05031825U02026-04-29
08404535019162Brasseler USA5031826U05031826U02026-04-29
08404535024227Axiom BladesBRAXM-GP8BRAXM-GP82026-04-29
08404535024258Axiom BladesBRAXM-FP14MBRAXM-FP14M2026-04-29
08404535024289Axiom BladesBRAXM-FC6BRAXM-FC62026-04-29
08404535024319Axiom BladesBRAXM-FP8SBRAXM-FP8S2026-04-29
08404535024340Axiom BladesBRAXM-HP8SBRAXM-HP8S2026-04-29
08404535024371Axiom BladesBRAXM-HP8MBRAXM-HP8M2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535024579Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024609Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024630Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024661Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
00840479201481RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-13
07908738730141DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730158DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730165DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730172DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730189DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730196DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730202DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730219DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730226DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730233DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730240DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730257DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730264DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730271DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730288DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730295DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730479DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730486DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730493DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730523DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730530DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730547DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738737775DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
00840479202495RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-11
00840479202501RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-11