FDA.reportPublic FDA data

PRODONT-HOLLIGER

Primary DI
03665224018087
Brand
PRODONT-HOLLIGER
Company
PRODONT-HOLLIGER
Model
194.13SI
Catalog number
194.13SI
Device description
modeling instr. bliss n2
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
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665224018087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665224018087036652240180873665224018087

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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
G8791021110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102305TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102335TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023580DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102477TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791024320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791024330DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791024340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791023940DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-10
G879102GS10DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS30DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS60DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H1H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H2H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H3H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20