FDA.reportPublic FDA data

PRODONT-HOLLIGER

Primary DI
03665224017714
Brand
PRODONT-HOLLIGER
Company
PRODONT-HOLLIGER
Model
419.01SI
Catalog number
419.01SI
Device description
burnisher machtou 1-1 bliss
Published
2021-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665224017714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665224017714036652240177143665224017714

GMDN Terms#

Term, Definition table
TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
275499887
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
03665224017684PRODONT-HOLLIGER419.04SI419.04SI2021-11-19
03665224017691PRODONT-HOLLIGER419.03SI419.03SI2021-11-19
03665224017707PRODONT-HOLLIGER419.02SI419.02SI2021-11-19
03665224017738PRODONT-HOLLIGER418.09SI418.09SI2021-11-19
03665224017745PRODONT-HOLLIGER418.08SI418.08SI2021-11-19
03665224017752PRODONT-HOLLIGER418.07SI418.07SI2021-11-19
03665224017769PRODONT-HOLLIGER418.06SI418.06SI2021-11-19
03665224017806PRODONT-HOLLIGER263.07SI263.07SI2021-11-19
03665224017813PRODONT-HOLLIGER263.06SI263.06SI2021-11-19
03665224000068PRODONT-HOLLIGERMZP511MZP5112021-11-19
03665224000099PRODONT-HOLLIGERMZP521MZP5212021-11-19
03665224000129PRODONT-HOLLIGERMZP531MZP5312021-11-19
03665224000150PRODONT-HOLLIGERMZP541MZP5412021-11-19
03665224000181PRODONT-HOLLIGERMZP551MZP5512021-11-19
03665224000662PRODONT-HOLLIGER1290.011290.012021-11-19
03665224000679PRODONT-HOLLIGER1290.021290.022021-11-19
03665224000686PRODONT-HOLLIGER1290.041290.042021-11-19
03665224000693PRODONT-HOLLIGER1290.071290.072021-11-19
03665224000709PRODONT-HOLLIGER1290.081290.082021-11-19
03665224000716PRODONT-HOLLIGER1290.131290.132021-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00348783009101Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009118Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
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