FDA.reportPublic FDA data

PRODONT-HOLLIGER

Primary DI
03665224018070
Brand
PRODONT-HOLLIGER
Company
PRODONT-HOLLIGER
Model
194.15SI
Catalog number
194.15SI
Device description
modeling instr. bliss n4
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
EKHCarver, Dental Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665224018070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665224018070036652240180703665224018070

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
D955CARWOOD11Paul BandittTerlain Enterprises, Inc.EKH2026-09-25
G8791024510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024520DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G879102453H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024540DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G879102455H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024570DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G149TBSB4090TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4100TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4110TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4120TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4130TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4280TBS BASICSACME ENTERPRISE.EKH2026-05-20
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10889950005399HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
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10889950005436HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005443HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005450HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005467HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005474HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005481HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005498HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005504HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005818HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005825HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006907HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12