FDA.reportPublic FDA data

PRODONT-HOLLIGER

Primary DI
03665224022251
Brand
PRODONT-HOLLIGER
Company
PRODONT-HOLLIGER
Model
108.14SI
Catalog number
108.14SI
Device description
burnisher dble n°14 bliss
Published
2021-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665224022251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665224022251036652240222513665224022251

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. 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
03665224017714PRODONT-HOLLIGER419.01SI419.01SI2021-11-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD28020Surgical DirectSurgical Direct, Inc.EKJ2026-07-31
00850083275655Intrace USAPILOTIS TECH LLCEKJ2026-07-03
00348783009378Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009361Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-03-17
10889950147372Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147389Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147716Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147747Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147754Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147761Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147792Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147884Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148065Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148102Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
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07898506811656QuinelatoSchobell Industrial LtdaEKJ2022-12-08
07898506843459QuinelatoSchobell Industrial LtdaEKJ2022-12-08
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