FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040033757
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007243
Catalog number
9007243
Device description
Maxima Diamond FG 855-012SC
Published
2019-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040033757PackageGS110In Commercial Distribution
10304040033750PrimaryGS10
00304040033753Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404003375720304040033757
1030404003375010304040033750
00304040033753003040400337533040400337530304040033753

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
true

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
B868CV1600010Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600020Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600030Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600040Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600050Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
B868CV1600060Prodia SelectABRASIVE TECHNOLOGY, INC.DZP2026-02-18
D690W368021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801009M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801012M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801023M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L018M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W802014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W802016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W811031M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16