FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950146405
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
TNFBL3
Device description
Composite Shaping Instrument, MOD 3D
Published
2025-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10889950146405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995014640510889950146405

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, reusableA hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889950157623Hu-FriedyI1308CE2LP2026-07-28
10889950157562Hu-FriedyIMN4120C22026-07-13
10889950157579Hu-FriedyIMN4122C22026-07-13
10889950154066PWR AirAPAIRPOL2026-01-14
10889950154080HuFriedyGroupDAPAIRPOL2026-01-14
10889950154103HuFriedyGroupLAPAIRPOL2026-01-14
10889950157517Hu-FriedyIMN4120C2F2026-06-23
10889950157524Hu-FriedyIMN4122C2F2026-06-23
10889950157531Hu-FriedyIMN4128C2F2026-06-23
10889950157326Hu-FriedyIMNO24511C2026-05-26
10889950147020Hu-FriedyDSBH5/662026-04-17
10889950157180Hu-FriedyIM40580-C42026-04-07
10889950157197Hu-FriedyIMN9142HAS2026-04-07
10889950126339Hu-Friedy MFG Co., LLC.CLAWXS2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.CLAWS2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.CLAWM2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.CLAWL2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.CLAWXL2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.CLAWXSX2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.CLAWSX2026-04-06

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