FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040113240
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1125714
Catalog number
1125714
Device description
Maestro Single-Use Polish Kit Composite Ea
Published
2019-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
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
00304040113240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040113240003040401132403040401132400304040113240

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

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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