FDA.reportPublic FDA data

EXCAVATOR DOUBLE ENDED

Primary DI
J003B0095035036001
Brand
EXCAVATOR DOUBLE ENDED
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
B009503503600
Catalog number
B009503503600
Device description
N/A
Published
2022-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKCEXCAVATOR, DENTAL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003B0095035036001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480538495
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J0030525020Z1Gutta Percha Points ISO0525020Z0525020Z2026-08-26
J0030525025Z1Gutta Percha Points ISO0525025Z0525025Z2026-08-26
J0030525030Z1Gutta Percha Points ISO0525030Z0525030Z2026-08-26
J0030525035Z1Gutta Percha points0525035Z0525035Z2026-08-26
J0030525040Z1Gutta Percha points0525040Z0525040Z2026-08-26
J0030525045Z1Gutta Percha points0525045Z0525045Z2026-08-26
J0030525050Z1Gutta Percha points0525050Z0525050Z2026-08-26
J0030525055Z1Gutta Percha points0525055Z0525055Z2026-08-26
J0030525060Z1Gutta Percha points0525060Z0525060Z2026-08-26
J0030525160Z1Gutta Percha points0525160Z0525160Z2026-08-26
J0030525165Z1Gutta Percha Points GP0525165Z0525165Z2026-08-26
J0030530F1Gutta Percha Points GP0530F0530F2026-08-26
J0030530FF1Gutta Percha Points GP0530FF0530FF2026-08-26
J0030530FFZ1Gutta Percha Points GP0530FFZ0530FFZ2026-08-26
J0030530FM1Gutta Percha Points GP0530FM0530FM2026-08-26
J0030530FMZ1Gutta Percha Points GP0530FMZ0530FMZ2026-08-26
J0030530FZ1Gutta Percha Points GP0530FZ0530FZ2026-08-26
J0030530L1Gutta Percha Points GP0530L0530L2026-08-26
J0030530M1Gutta Percha Points GP0530M0530M2026-08-26
J0030530MF1Gutta Percha Points GP0530MF0530MF2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791022620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022630DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022640DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022970DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027580DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027600DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G87910217W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910218W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910219W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022450DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX11L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX32L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX33L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
00850083275624Intrace USAPILOTIS TECH LLCEKC2026-07-03
00348783008500Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008517Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008524Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008531Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008548Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08