FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950131975
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
CIBIOY
Device description
Bio-Emulation Gamma, Comp Inst
Published
2022-07-14
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
10889950131975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995013197510889950131975

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, resinA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin 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

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
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
10889950126407Hu-Friedy MFG Co., LLC.CLAWMX2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.CLAWLX2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.CLAWXLX2026-04-06
10889950001643Hu-Friedy Mfg. Co., LLCPSN6953LPSN6953L2015-10-16
10889950001834Hu-Friedy Mfg. Co., LLCPSN7773LPSN7773L2015-10-16
10889950002060Hu-Friedy Mfg. Co., LLCPSNR683LPSNR683L2015-10-16
10889950002077Hu-Friedy Mfg. Co., LLCPSNR698LPSNR698L2015-10-16
10889950002084Hu-Friedy Mfg. Co., LLCPSNR7772LPSNR7772L2015-10-16
10889950156008Hu-FriedyIM53FMC22026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817169029281Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEIY2026-03-05
00840018672628Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-11
00840018667167Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018667242Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018667464Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671768Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671775Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018665675Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665804Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665811Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666047Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666085Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666993Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018663381Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-04
00840018663626Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-04
00840018663190Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018663213Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018661622Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
00840018661639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
07649988629341OdneFill Tips 25mmOdne AGEIY2025-09-03
05010058178083InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-23
05010058178694InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-19
00303620001434Septodont Multi-Use DispenserSEPTODONT SAS SPECIALITES SEPTODONTEIY2025-05-29
00766054002987Turbo-CRESSENTIAL DENTAL SYSTEMS, INC.EIY2025-04-04
00889813066898Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066904Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066911Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066928Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066935Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066942Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12