FDA.reportPublic FDA data

BENCO

Primary DI
00366975048868
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
5304-547
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EILGauge, Depth, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975048868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975048868003669750488683669750488680366975048868

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose calliper, metallicA manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015108087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975069993Sterling6694-6422025-02-26
00366975070005Sterling5259-5162025-02-26
00366975069344STERLING5259-507 2024-01-26
00366975013040STERLING5259-5072023-12-13
00366975012814STERLING4983-5662023-06-13
00366975066848OPTIMUM6032-0532023-02-21
00366975066855OPTIMUM6032-0712023-02-21
00366975066862OPTIMUM6032-0802023-02-21
00366975066879OPTIMUM6032-0992023-02-21
00366975066886OPTIMUM6032-1062023-02-21
00366975066893OPTIMUM6032-1152023-02-21
00366975066909OPTIMUM6032-1242023-02-21
00366975066916OPTIMUM6032-1332023-02-21
00366975066923OPTIMUM6032-1422023-02-21
00366975066930OPTIMUM6032-1512023-02-21
00366975066947OPTIMUM6032-1602023-02-21
00366975066954OPTIMUM6032-1792023-02-21
00366975066961OPTIMUM6032-1972023-02-21
00366975066978OPTIMUM6032-2042023-02-21
00366975066992OPTIMUM6032-2312023-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D9098000661ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D9098000671ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D9098000681ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D909800081C1ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
00842092186626PreatPreat CorporationEIL2025-09-05
D9098000341ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980008114ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013716ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013918ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980014010ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
00194613114893MSI Precision Specialty InstrumentsMed Saver, Inc.EIL2025-08-01
E8961732150SCHWERTA. Schweickhardt GmbH & Co. KGEIL2025-04-07
EZPF2474408HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIL2025-03-07
00371347018318Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00371347018356Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00841336121584Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIL2024-12-11
00190730084682Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084811Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084828Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084835Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084842Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084859Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
08800016113303Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016113488Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121612Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121629Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121636Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121643Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121650Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121667Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08